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Albany Medical College Orthopaedic Journal
Comparison of Computer Monitors in Evaluating Digital Radiographs for the Diagnosis of Scaphoid
Fractures
Justin M Ferrara, MD, Paul Hospodar, MD, Richard L. Uhl, MD, Erin L. Kaufman, MPH ........................................3

The Effects of Non-enzymatic Glycation on Cancellous Bone: A Comparison between Hip Osteoarthritis and
Hip Fractures
Michael Mulligan, MD, Lamya Karim, Joseph Bellapianta, MD, Jared Roberts, MD, Richard L. Uhl, MD,
Deepak Vashishth, Ph.D. ................................................................................................................................................8

How Much Motion is There in the Normal Scapholunate Joint?


Richard L. Uhl, MD, Mitchell Campito, MD, Miguel Perela-Cruz, MD.....................................................................14

Displaced Intra-articular Calcaneal Fractures Comparison of Two Different Surgical Techniques: Modified
Palmer’s Approach and Extensile Lateral Approach: Early Complications, Radiographic Findings and
Outcomes
Camilo Guzman, MD, Paul Hospodar, MD, John DiPreta, MD, Paul Johnson, MD...................................................17

Comparison of Endoscopic and Open Carpal Tunnel Release in the Same Patient
Ali Hashemi, MD, Richard Whipple, MD, Erin L. Kaufman, MPH............................................................................25

Total Shoulder Arthroplasty vs. Hemiarthroplasy for Osteoarthritis: A Retrospective Review of


Clinical Outcomes
Brent Carlson, MD, John Czajka, MD, Toni Hansen, CCRC, Patrick Marinello, Ashar Ata . ....................................28

Adjacent Level Effects: A Novel In Vivo/In, Vitro Active/Passive Protocol for Assessing Redistribution of Mo-
tion of the Entire Thoracolumbar Spine Following Surgical Intervention
Kyle A Elsabee, John D. Wason, James Boyle, MD, Ronniel Nazarian, MD, John T. Wen, Ph.D.,
Allen L. Carl, MD, Eric H. Ledet, Ph.D. .....................................................................................................................32

The Role of Extensor Muscle Fatigue in the Onset of Intervertebral Disc Degeneration: An In Vivo Model
Mary Beth M. Grabowsky, MS, Nicholas A. Pallotta, MS, Matthew W. Connelly, MS, Brett Van Etten, Rebecca A.
MacDonald, MS, Maxwell Alley, Joseph C. Glennon, VMD, Andrew H. Dubin, MD, John W. German, MD,
Richard L. Uhl, MD, Eric H. Ledet, Ph.D....................................................................................................................40

In Vivo Effects of Cyclic Compression on the Intervertebral Disc and Endplates of the Lumbar Spine:
A Pilot Study with a Novel Animal Model
Glenn P. Sanders, Ph.D., Sarah E. Linley, Gwendolyn A. Sowa, MD, Ph.D., Joseph C. Glennon, VMD, Darryl J.
DiRisio, MD, James P. Lawrence, MD, Jacqueline Vanderzanden, MD, Elizabeth Leimer, Jeffrey C. Lotz, Ph.D.,
Eric H. Ledet, Ph.D.......................................................................................................................................................48

The Effect of Anti-Rotation and Anti-Cutout Features in Cephalomedullary Nail Fixation of


Intertrochanteric Femur Fractures: An Acute Biomechanical Study
Matthew W. Connelley, MS, Jared Roberts, MD, Rosemary Buckle, MD, Eric H. Ledet, Ph.D. ...............................60

RPI 2010 Senior Design Showcase.............................................................................................................................70

Albany Medical College, Division of Orthopaedic Surgery Grand Rounds.........................................................72

The Albany Medical College Orthopaedic Journal is an annual publication of the Division of Orthopaedic Surgery at the Albany
Medical College. If you have any questions, or would like to add your name to our mailing list, you are welcome to contact us
at Albany Medical College Orthopaedic Journal, 1367 Washington Ave, Suite 202, Albany, NY 12206. You are also welcome to
contact us via phone at 1-518-453-3074 or fax at 1-518-453-1463.
1
Albany Medical College Orthopaedic Journal
Richard L. Uhl, MD
Professor
Editor-in-Chief
James P. Lawrence, MD
Assistant Professor
Deputy Editor – Research
Michael Mulligan, MD
Assistant Professor
Deputy Editor – Clinical
Eric H. Ledet, Ph.D
Assistant Professor, Rensselaer Polytechnic Institute
Deputy Editor – Biomedical Engineering

Toni Hansen, CCRC


Research Coordinator
Managing Editor
Kathy Pangburn
Residency Coordinator

Editorial Review Board


Richard H. Alfred, MD John A. DiPreta, MD Jordan M. Lisella, MD
Clinical Associate Professor Clinical Associate Professor Clinical Assistant Professor
Sports Medicine Foot & Ankle Foot & Ankle

R. Maxwell Alley, MD Andrew H. Dubin, MD Jeffrey Lozman, MD


Clinical Assistant Professor Clinical Associate Professor Clinical Professor
Sports Medicine Physical Medicine & Adult Reconstructive
Rehabilitation
Kaushik Bagchi, MD Daniel T. Phelan, MD
Assistant Professor Marc D. Fuchs, MD Clinical Assistant Professor
Trauma & Adult Reconstructive Professor Sports Medicine
Adult Reconstructive
Robert A. Cheney, MD David E. Quinn, MD
Clinical Assistant Professor Andrew C.Gerdeman, MD Clinical Assistant Professor
Spine Surgery Clinical Assistant Professor Hand & Upper Extremity
Sports Medicine
John Czajka, MD Richard R. Whipple, MD
Clinical Associate Professor Robert J. Hedderman, MD Clinical Assistant Professor
Adult Reconstructive Clinical Assistant Professor Hand & Upper Extremity
Pediatric Orthopaedics General Orthopaedics
George Zanaros, MD
Shankar P. Das, MD Paul P. Hospodar, MD Clinical Assistant Professor
Clinical Assistant Professor Associate Professor Hand & Upper Extremity
Sports Medicine Trauma & Adult Reconstructive
2
Comparison of Computer Monitors in Evaluating Digital Radiographs for the Diagnosis of
Scaphoid Fractures
Justin M. Ferrara, MD, Paul Hospodar, MD, Richard L. Uhl, MD, Erin L. Kaufman, MPH
Division of Orthopaedic Surgery, Albany Medical College, Albany, NY

Presented at the 2008 AMC Orthopaedic Surgery Annual Resident Thesis Day

Background: The diagnosis of acute scaphoid fractures can be a challenge. Advances in technology have lead to
the increased use of digital radiographs as opposed to actual radiographs in the evaluation of musculoskeletal in-
jury.  There is much variation in the quality of the monitors used to evaluate these studies.  This study compares
personal computer (PC) monitors and picture archiving and communication system (PACS) monitors in the evalu-
ation of non-displaced scaphoid fractures.   The purpose of this study is to retrospectively compare the ability of
orthopaedic surgeons to identify scaphoid fractures on digital radiographs using a PC and a PACS monitor.     

Methods: Twenty-five patients who had previously been diagnosed in an outpatient orthopaedic setting with an
acute, non-displaced scaphoid fracture were identified from a review of patient charts.  A control group of twenty-
five subjects with a diagnosis of wrist sprain who had wrist radiographs taken were also identified.  All subjects
had wrist radiographs that included a posterioanterior view, a posterioanterior view with ulnar deviation, and a
lateral view. Two orthopaedic attending surgeons reviewed the radiographs of both groups while being blinded to
the diagnoses.  The reviewers evaluated for the presence or absence of scaphoid fracture. 

Results: The reviewers correctly identified a non-displaced scaphoid fracture in 44 of 50 radiographic images
using the PC monitors. The reviewers correctly identified a negative radiographic image (no fracture) in 46 of 50
radiographic images using the PC monitors. This represents a sensitivity of 0.88 and a specificity of 0.92 for the
PC monitor. Using the PACS monitors, the reviewers correctly identified a non-displaced scaphoid fracture in 39
of 50 radiographic images. The reviewers correctly identified a negative radiographic image (no fracture) in 45 of
50 radiographic images using the PACS monitors. This represents a sensitivity of 0.78 and a specificity of 0.90 for
the PACS monitors.

Conclusions: Orthopaedic surgeons are justified in their use of PC monitors in the evaluation of non-displaced
scaphoid fractures. PACS monitors do not offer the orthopaedic surgeon additional diagnostic power.
Introduction Many orthopaedic offices use personal computer moni-
The diagnosis of acute scaphoid fractures can be a tors as opposed to a picture archiving and communication
challenge.2,8,11  There may not be obvious radiological system (PACS) used by radiologists.  Currently there
evidence of fracture until several weeks after the initial are no formally defined standards or specific guidelines
injury, and ultimately additional radiographic studies may for the type of monitor used in the evaluation of digital
be require to make a diagnosis.1 Non-displaced scaphoid radiological studies.4-6, 8   There are significant differences
fractures can be subtle, even when being evaluated with in quality of monitor used in the orthopaedic outpatient
the highest quality monitors used by radiologists.2,4,8,11 Ac- setting compared to those used by radiologists.4, 6 
cording to Pillai and Jain, the incidence of true scaphoid There are varying opinions as to the optimal
fractures with initially negative radiographs is 6.66%.8  number of views that need to be taken to diagnose a sca-
Conventional x-rays miss these types of fractures on the phoid fracture.7,10   When consulting orthopaedic surgeons,
patient’s initial presentation.7  57.5% preferred four views, while 33.3% preferred three
Advances in technology have lead to the in- views.7,10  The majority of consulted radiologists preferred
creased use of digital radiographs as opposed to actual four views (68.4%) while 15.8% preferred three views.7,10 
radiographs in the evaluation of musculoskeletal injury.4  There is no known literature that evaluates the number of
There is much variation in the quality of the monitors used views preferred in America.  Our study will utilize three
to evaluate these studies.4, 6   Radiologists tend to utilize views: posterioanterior, lateral, and posterioanterior with
higher quality monitors, which optimize brightness, lumi- ulnar deviation. 
nance, and resolution.  Radiologists’ monitors generally The PACS system has several qualities that make
either undergo periodic self-checks or have formal quality it unique.  It is composed of several components which
assurance evaluation performed by the radiology staff.  include a digital device, a network with a bandwidth be-
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tween 10 and 50 megabytes/study, an archiving device, wrist radiographs taken at their initial visit (ICD-9 code
diagnostic workstations and software that has archiving 842.00).  All subjects had wrist radiographs that included
and routing features. 9    The benefits of having a PACS a posterioanterior view of the wrist, a posterioanterior
system include, cost savings as compared to conventional view of the wrist with ulnar deviation, and a lateral view
radiographs, productivity improvements, superior image of the wrist. 
quality, decreased interpretation time, and an avenue for A fifth year orthopaedic resident selected sub-
rapid consultation with other specialists.9   The PACS jects and radiographic images (JMF).   The patient data-
system can be expanded to include additional worksta- base used to identify the subjects came from the Capital
tions and may utilize the Internet to allow the films to Region Orthopaedic Group billing office (Albany, NY). 
be accessed outside of the facility by other consultants.9  The database included all patients with the diagnosis of a
Several studies have demonstrated no statistical diagnostic scaphoid fracture and wrist sprain in the last four years,
difference between the PACS workstation and personal the beginning of the utilization of digital imaging at this
computer monitors.3,4 The PACS monitors are not routinely facility.  Fractures deemed to be acute, non-displaced,
utilized in the outpatient orthopaedic settings likely due to and without concomitant pathology in skeletally mature
the additional cost associated with such systems.  patients were included.  All radiographs were taken at
An acute scaphoid fracture is a diagnosis that is the Bone and Joint Center.  The Bone and Joint Center/
commonly made in the orthopaedic office setting, without Capital Region Orthopaedic Group is a private, outpatient
the assistance of a radiologist and/or the PACS monitor.  facility closely affiliated with Albany Medical Center Di-
The recent trend is for offices to become “filmless” as vision of Orthopaedics.  Typical radiographs used in the
computer technology improves to the point of digital study are shown in Figure 1A, 1B, and 1C.
radiograph quality rivaling that of the printed radiograph.  Two orthopaedic attending surgeons (RLU, PH)
Prior study has demonstrated that  the benefit of routine reviewed the radiographs of both groups while being
duplicate radiograph interpretation by both an orthopaedist blinded to the subjects’ diagnoses.  Each subject was ran-
and a radiologist does not justify its cost.12 domly assigned a number and the subject’s name and sex
Our study compared two systems (PC and PACS were removed from the radiograph.  The radiographs were
monitors) in the evaluation of non-displaced scaphoid evaluated for the presence or absence of scaphoid fracture. 
fractures.  The null hypothesis was that there was no Both reviewers evaluated all subjects first on the PC moni-
statistically significant difference in the identification of tor and then on the PACS monitor.  The order of the cases
scaphoid fractures in digital radiographs evaluated by at- was random. The reviewers were allowed to magnify the
tending orthopaedic surgeons using either a PC monitor digital images as each monitor’s system allowed. 
or the PACS monitor. The purpose of this study was to The data was calculated for the positive and
retrospectively compare the ability of orthopaedic surgeons negative predicted value, sensitivity, and specificity.  A
to identify non-displaced scaphoid fractures on digital chi-square was used to determine the significance of the
radiographs using PC and PACS monitors.    variables.  Power was recalculated at the end of the study
to determine the true statistical power of the study.
Materials and Methods The study protocol was approved by the Albany
The study population consisted of adults aged 18 and older.  Medical Center’s Institutional Review Board and carried
The experimental group consisted of 25 patients who were out in accordance with the Declaration of Helsinki of the
identified with a diagnosis of an acute non-displaced sca- World Medical Association.  Informed consent was not
phoid fractures at their initial visit (ICD-9 code 814.00). required.
The control group consisted of 25 subjects who ruled out
for scaphoid fractures (wrist sprain diagnosis) but had

Figure 1A, 1B, and 1C.  1A- P/A wrist, 1B-P/A wrist with ulnar deviation, 1C-
lateral wrist in a study subject with scaphoid fracture.     
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Table 1: Subject Characteristics for the Two Groups
Scaphoid fracture Non-fractured group
Variable p-value
group (N=25) (N=25)
Age (Mean) 33 39 0.27
Sex (M:F) 17:8 9:16 <0.0001, 0.007
Wrist laterality (R:L) 15:10 14:11 0.057, 0.271

Results  led to a positive predictive value of 0.89 and a negative


The radiographic images were evaluated by the two predictive value of 0.80. The positive predicitive value
reviewers separately on both the PC and the PACS moni- is the proportion of patients with positive test results who
tors. There were twenty-five subjects with non-displaced are correctly diagnosed. The negative predictive value is
scaphoid fractures and twenty-five subjects without a the proportion of patients with negative test results who
scaphoid fracture (wrist sprain). The mean age for the are correctly diagnosed.
subjects in the fracture group is 33 years. The mean age for There were a total of 26 of 100 images that were
the subjects in the non-fractured group is 39 years. There evaluated and diagnosed incorrectly. The data collection
are 17 male subjects and 8 female subjects in the fracture sheet contained a question regarding the recommended
group. There are 9 male subjects and 16 female subjects treatment based on the diagnosis, either conservative or
in the non-fractured group. The subject characteristics surgical management. An incorrect diagnosis resulted in
can be seen in Table 1. a change in the treatment recommendation in only one
The data from the two reviewers were combined case. The radiograph was incorrectly read as showing a
such that for each system evaluation (PC or PACS) there scaphoid fracture using the PACS monitor and surgical
were data from fifty images demonstrating a scaphoid intervention was recommended. Surgical intervention
fracture and fifty images without a scaphoid fracture. was recommended in only 5 other cases, all of whom were
The reviewers correctly identified a non-displaced correctly diagnosed with a scaphoid fracture. Three of
scaphoid fracture in 44 of 50 radiographs using the PC these recommendations were made when evaluating the
monitors. The reviewers correctly identified a negative images with the PACS monitor and two were made using
radiographic image (no fracture) in 46 of 50 radiographs the PC monitor.
using the PC monitors. This represents a sensitivity of The data collection sheet used by the reviewers
0.88 and a specificity of 0.92 for the PC monitor. Using contained a question regarding the desire for additional
the PACS monitors, the reviewers correctly identified a imaging to further clarify the diagnosis. The reviewers
non-displaced scaphoid fracture in 39 of 50 radiographs. would have liked to have reviewed additional images for
The reviewers correctly identified a negative radiographic diagnostic purposes in 84 of 100 in the non-fractured group
image (no fracture) in 45 of 50 radiographs using the PACS and in 72 of 100 in the fracture group.
monitors. This represents a sensitivity of 0.78 and a speci- The data collection sheet also asked the review-
ficity of 0.90 for the PACS monitors. This information is ers their opinion of the quality of the radiographic image.
represented in Table 2. The image was judged as good, fair, or poor. Of the PC
Further extrapolating these data gives a positive images, 46 were rated as good, 47 as fair, and 7 as poor.
predictive value of 0.92 and a negative predictive value Of the PACS images 87 were rated as good, 12 as fair, and
of 0.88 for the PC monitor. The PACS monitor’s results 1 as poor (see Table 3).

Table 2: Results of the Radiographic Image Review Using PC and PACS Monitors
  Scaphoid fracture group Non-fractured group  
  Correct Incorrect Correct Incorrect
Sensitivity Specificity
Reading Reading Reading Reading

PC 44 (88%) 6 (12%) 46 (92%) 4 (8%) 0.88 0.92

PACS 39 (78%) 11 (22%) 45 (90%) 5 (10%) 0.78 0.90

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Table 3: Image Quality as Rated by the Reviewers
    PC PACS
Good 46 87
Image Quality
Fair 47 12
Poor 7 1

Discussion sample size was not sufficient enough to give this study
Prior investigation in the radiology literature demonstrated adequate power, there was no meaningful difference be-
no difference in the detection of wrist fractures with PC tween the two systems evaluated.
compared to PACS.4   In that study, Doyle et al. evalu- Over the course of this study, the reviewers did
ated the ability of radiologists to detect wrist fractures.  occasionally arrive at the wrong diagnosis.  This occurred
However, Liang et al. demonstrated a significant difference in 26 of 100 radiographs. The largest percentage of these
in the ability of radiologists to detect fractures on digital occurred using the PACS monitors in a group of subjects
radiographs using two different monitors.6 There currently that had scaphoid fractures, but were diagnosed as hav-
remains no formally defined standards or specifications ing no fracture. This inability to diagnose a fracture did
for the types of monitors used to read digital radiographic change the treatment that was recommended based on the
images.13   Brem et al. demonstrated that low-cost com- radiographic evaluation in one case.     
puter monitors could be safely used to detect cervical spine This study lends evidence to the notion that
fractures in the emergency department.3  orthopaedic surgeons are justified in their use of PC moni-
In the orthopaedic clinic setting, it is common tors in the evaluation of digital imaging for the purpose
practice for orthopaedic surgeons to evaluate the radio- of identifying fractures.  With a sensitivity of 0.88, the
graphs taken in their office.  Prior study has demonstrated reviewers were able to diagnose non-displaced scaphoid
that  the benefit of routine duplicate radiograph interpre- fractures using a PC monitor to evaluate digital images
tation by both an orthopaedist and a radiologist does not without difficulty.
justify its cost.12 Routine radiological consultation of This study has several limitations. Recall bias
radiographs in the orthopaedic setting is unnecessary. cannot be excluded in the reviewers’ interpretation of the
Major savings in health-care costs can be seen by not images even though they were presented in random order
routinely undertaking radiological consultation for elec- each time.  They may have recognized the images in the
tive orthopaedic problems.14 In many office settings plain second evaluation, however the reviewer would still have
radiographs are no longer printed, but rather are digitally been blinded to the true diagnosis.  There was a lack of
stored and evaluated via computer by the orthopaedic power in this study making it difficult to generalize the
surgeon.  results to a broader population.  The focus of this study
This study demonstrates that there was no clear was on the presence of a scaphoid fracture therefore it
advantage in using the PACS by orthopaedic surgeons to is difficult to generalize to a wider variety of fractures. 
evaluate wrist radiographs for scaphoid fractures.  There Bias may have been introduced by the fact that one of the
was no significant difference in the ability of the review- systems to be evaluated by the study (the PC monitor) was
ers to determine the presence of a non-displaced scaphoid used to make the original diagnosis.
fracture using the conventional PC monitor or the PACS This study represents further justification for
monitor.  Using the PC monitor a sensitivity of 0.88 and a the use of personal computer monitors in the evaluation
specificity of 0.92 were demonstrated. The PACS monitors of skeletal fractures by the orthopaedic surgeon. PACS
demonstrated a sensitivity of 0.78 and a specificity of 0.90 monitors do not offer the orthopaedic surgeon additional
in the identification of the scaphoid fractures. While the diagnostic power.

References

1.  Adey L, Souer JS, Lozano-Calderon S, Palmer W, 2.  Ballas MT, Tytko J, Mannarino F. Commonly missed
Lee SG, Ring D. Computed tomography of suspected orthopedic problems. Am Fam Physician. 1998; 57(2):
scaphoid fractures. J Hand Surg Am. 2007; 32(1): 61- 267-74.
67.

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3.  Brem MH. et al.: Evaluation of low-cost computer 9.  Robertson I. Image dissemination and archiving. Clin
monitors for the detection of cervical spine injuries in Tech Small Anim Pract. 2007;22(3): 138-44.
the emergency room: an observer confidence-based
10.  Shenoy R, Pillai A, Hadidi M. Scaphoid fractures:
study. 2006; Emerg Med J, 23(11): 850-3.
variation in radiographic views - a survey of current
4.  Doyle AJ, Le Fevre J, Anderson GD. Personal com- practice in the West of Scotland region. Eur J Emerg
puter versus workstation display: observer performance Med. 2007;14(1): 2-5.
in detection of wrist fractures on digital radiographs.
11.  Welling RD, Jacobson JA, Jamadar DA, Chong S,
Radiology. 2005; 237(3): 872-7.
Caoili EM, Jebson PJ. MDCT and radiography of wrist
5.  Krupinski EA, Kallergi M. Choosing a radiology fractures: radiographic sensitivity and fracture patterns.
workstation: technical and clinical considerations. AJR Am J Roentgenol. 2008;190(1): 10-6.
Radiology. 2007; 242(3): 671-82.
12.  Anglen J, Marberry K, Gehrke J. The clinical utility
6.  Liang Z, Li K, Yang X, Du X, Liu J, Zhao X, Qi of duplicate readings for musculoskeletal radiographs.
X. ROC analysis for diagnostic accuracy of fracture Orthopedics. 1997;20(11):1015-9.
by using different monitors. J Digit Imaging. 2006;
13.  Andriole K. Display monitors for digital medi-
19(3): 276-8.
cal imaging.  American College of Radiology. 2005;
7.  Parvizi J, Wayman J, Kelly P, Moran CG. Combin- 543-6.
ing the clinical signs improves diagnosis of scaphoid
14.  Zohman G, Watts H. Is routine radiological
fractures. A prospective study with follow-up.  J Hand
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8.  Pillai A, Jain M. Management of clinical fractures of 549-51.
the scaphoid: results of an audit and literature review.
Eur J Emerg Med. 2005;12(2): 47-51.

7
The Effects of Non-enzymatic Glycation on Cancellous Bone:
A Comparison between Hip Osteoarthritis and Hip Fractures
Michael Mulligan, MD*, Lamya Karim°, Joseph Bellapianta, MD*, Jared Roberts, MD*,
Richard Uhl, MD*, Deepak Vashishth, Ph.D°
*Division of Orthopaedic Surgery, Albany Medical College, Albany, NY
°Department of Biomedical Engineering, Rensselaer Polytechnic Institute, Troy, NY

Presented at the 2008 AMC Orthopaedic Surgery Annual Resident Thesis Day

Background: The non-enzymatic glycation (NEG) of tissue has been shown to occur as a normal consequence of
aging.   Whether the accumulation of advanced glycation end products (AGEs) contributes clinically to osteo-
porotic fragility fractures is not well understood.  We hypothesized that cancellous bone from individuals who
sustained a hip fracture would have higher levels of AGEs than patients without fractures, and that these samples
would fail under less biomechanical compression. 
 
Methods: A total of eighteen femoral heads were used.  One group consisted of nine patients with hip osteoar-
thritis undergoing total hip arthroplasty, and a second group contained nine patients who sustained a femoral neck
fracture requiring hip hemiarthroplasty.  Cores of bone were mechanically tested to determine stress/strain proper-
ties.  Non-enzymatic glycation was measured through described methods utilizing photochemistry.
 
Results: The bone from the hip fracture group was an average of 54% weaker than the bone from the osteoar-
thritic group (p<0.05).  The NEG content was nearly 12% higher in the hip fracture group, but this value was not
statistically significant. 
 
Conclusions: This study demonstrates the phenomenon of NEG occurs in the cancellous bone collagenous matrix
of both osteoarthritic and osteoporotic patients and may contribute in different ways to these disease processes. 
Based on previous research, the increase in NEG within fractured bone helps explain that under compression it
behaved in a significantly more brittle manner.  If further data shows a significant increase in AGE levels in osteo-
porotic patients compared to others of similar ages, then we may have another target for the treatment of osteopo-
rosis and the prevention of fragility fractures.
Introduction It has been shown that as a natural consequence
Hip fractures and their associated morbidity are a signifi- of aging, a gradual decline in bone mass occurs on the
cant public health care concern in this country. In older order of 0.3 to 0.5% a year starting by the age of 303. Hu-
patients, hip fractures often occur as a result of increased man bone is in a constant state of remodeling secondary
fragility of the proximal femur due to osteoporosis, de- to a delicate coupling at the cellular level of osteoblast
fined as a “systemic skeletal disorder characterized by a mediated bone formation and osteoclast mediated bone
quantitative deficit of bone mass and micro-architectural resorption. In comparing the main types of human adult
breakdown of bone tissue”1. We are an ever-aging soci- bone, the turnover rate of cancellous bone is approximately
ety, with the elderly population being the fastest growing eight times that of cortical bone. This is because cancel-
segment. It is predicted that worldwide hip fractures will lous bone occupies a larger amount of surface area in the
reach epidemic proportions; rising from about 1.7 million human skeleton, and thus it is this type of bone which is
in 1990 to 6.3 million in the next forty years. It is estimated affected most by osteoporosis. While this loss of bone
1 in 3 women and 1 in 12 men will suffer a hip fracture mass over time occurs macroscopically, it is also well
during their lifetime1. The impact here goes well beyond established that there are corresponding changes within
the health care system’s ability to handle this growing bone at the molecular level. Specifically, the collagen
census of patients, as research indicates that only about matrix undergoes various biochemical reactions as the
50% of these patients are able to regain their pre-fracture body ages. Numerous studies support the concept that
ambulatory status2. An alarming financial burden is also collagen plays a substantial role in the ability of bone to
on the horizon, with costs of over $20,000 per patient for absorb energy, defined as its toughness. Collagen makes
the first year after fracture alone and an estimated $131,500 up 90% of the organic phase of bone and subsequently
million total cost by the year 20501. undergoes a variety of biosynthetic events which alter its

8
properties4. In particular, advanced glycation end products A total of eighteen femoral heads were used for
(AGEs) can be made as posttranslational modifications to this study. The first experimental group consisted of nine
collagen when reducing sugars react non-enzymatically patients with degenerative hip disease having total hip
with free amino groups in lysine, hydroxylysine or arginine replacement surgery. The second group was composed
residues. These products can act as adducts to proteins or of nine patients who sustained a displaced femoral neck
even create covalently bonded collagen cross-links5. fracture requiring hip hemiarthroplasty. Of note, all cases
Previous research has documented that this of femoral neck fracture occurred from a fall from stand-
process of non-enzymatic glycation (NEG) occurs in the ing height, which is defined by the literature as fragility
extra-cellular matrix of many human tissues, including fracture1. Patients with rheumatoid arthritis, congenital or
bone. Investigators have shown that NEG of collagen, not acquired dysplasia, or other inflammatory arthropathy were
only increases with age, but also has a negative impact on excluded from the study. Blood samples were collected
the mechanical properties of both cortical and cancellous from each patient in accordance with the requirements for
bone7,8. In vitro models of NEG demonstrate a change human tissue handling at Rensselaer Polytechnic Institute
in post-yield properties such that the altered bone has a (RPI) in Troy, NY. Hemoglobin A1c (HbA1c ) levels, which
decreased capacity to accumulate damage and dissipate are proportional to a patient’s average blood glucose con-
energy8. Recent utilization of 3D Cat Scan and finite centration over the previous four weeks to three months,
element analysis to measure bone geometry and trabecular were also drawn.
connectivity has called into question our current methods
of calculating bone mass and mineral density, citing their Mechanical Testing
inconsistent predictions of bone strength9. Given that most A drill press with a modified jig was used to obtain mul-
fragility fractures secondary to osteoporosis are of cancel- tiple cores of cancellous bone from each femoral head.
lous bone, a more complete understanding of cancellous The cores measured approximately 8mm in diameter and
bone fragility at the molecular level would allow us to 20mm in length. They were taken in line with the princi-
better assess the risk of age-related osteoporotic fractures. pal compressive trabeculae orientation of the bone. This
The goal of this study is to examine the NEG process in orientation was pre-determined using plain radiographs of
vivo as it pertains to the clinical entities of degenerative the femoral heads. The cores were then cut into 8-10mm
hip arthritis and femoral neck fractures. We hypothesize sections under constant hydration (ISOMET 11-1180,
that, with controlling for age, cancellous bone samples Buehler Corp., Lake Bluff, IL). The final core measure-
from individuals who sustain hip fractures will (1) have ments averaged 7.6±0.3mm in diameter and 8.6±0.9mm
higher concentrations of NEG compared to patients with- in length. Between testing, samples were submerged in
out fractures and will (2) fail under less biomechanical normal saline and stored at -80°C.
compression than those samples from individuals who Mechanical testing of cores from degenerative
have osteoarthritis. and fractured femoral heads was conducted using an MTS
Bionix 858 hydraulic servo mechanical testing station
Materials and Methods (MTS, Eden Prairie, MN). Each specimen was glued to
Sample Selection brass endcaps and loaded to failure in unconfined com-
After Institutional Review Board approval was granted pression at 833 microstrains/second at 37 degrees Celsius
and informed consent was obtained from each study under constant hydration. Load-displacement data was
participant, the entire femoral head including a portion collected during testing, and stress-strain curves were
of the femoral neck was taken from patients undergoing created. The following parameters were then calculated:
both total hip arthroplasty procedures and hip hemiar- (1) elastic modulus; (2) yield stress and strain (determined
throplasties. All surgeries were completed at Albany using the 2% offset method); (3) ultimate stress and strain
Medical Center (Albany, NY) between the periods (defined as the point of maximal load); and (4) post-yield
of October 2006 through November 2007. Care was strain (defined as the difference between the ultimate and
taken intra-operatively in order to minimize damage to yield strain values). Student t-tests were used to evaluate
the cancellous bone within the bone sample as it was the differences due to the underlying disease process of
removed from the patient. A section of bone was taken each experimental group, with the level of significance
from the portion of the femoral neck in each case so that set at P=0.05.
it could be evaluated by the pathology department per
standard protocol. The remaining bone was preserved Determination of NEG
in saline soaked gauze and deep frozen at -80°C until After completing the mechanical testing, the nine cancel-
it was time for specimen preparation and mechanical lous bone specimens from each experimental group were
testing. decalcified with a 20% solution of 90% formic acid diluted

9
Figure 1. Comparison of age between hip osteoarthritis
and femoral neck fracture groups. No significant differ- Figure 2. Comparison of HbA1c levels between groups.
ence was noted. (Student’s t-test, p =0.26). No significant difference was noted. (Student’s t-test, p
= 0.21).
with deionized water. The solution was changed daily
until the presence of calcium was no longer detected by
a calcium determination assay. The specimens were then Hemoglobin A1c Levels
digested with papain collagenase (0.4 mg/ml in 0.1 mM The mean HbA1c level from blood samples of the nine
sodium acetate buffer, pH 6.0, 16 h, 65 degrees Celsius). patents undergoing total hip arthroplasty for degenera-
NEG content was quantified using fluorescence readings tive joint disease was 5.79. The average level from blood
taken with a Synergy-HT Microplate reader at wavelengths samples of the nine patients sustaining a femoral neck
of 360nm excitation and 460nm emission (BioTek USA, fracture was 6.32. Both of these values were within normal
Winooski, VT) against a quinine sulfate standard. The reference ranges for our lab (4.1-6.5), and no statistical
amount of collagen in each cancellous bone sample was difference between the two groups was found (Figure 2).
estimated based on the level of hydroxyproline8. The
content of hydroxyproline was determined by recording Mechanical Testing
the absorbance of digested specimens against a standard at In comparison to bone taken from patients who sustained
570nm wavelength using a Dynatech MR-600 Microplate a hip fracture, there was about a 54% average increase in
reader (Dynatech Inc., Alexandria, VA). elastic modulus (stiffness) for the bone taken from patients
with osteoarthritis; however, this difference was not sta-
Results tistically significant (p=0.20). In addition, no significant
Patient Demographics differences were found between the groups with respect to
In the degenerative hip disease group, there were five yield stress, yield strain, ultimate stress or ultimate strain
males and four females, with an average overall age of (Table 1). The data for post yield strain demonstrated an
78. In the hip fracture group, there were three males and average 116% increase within the osteoarthritic bone,
six females, with an average overall age of 82. The two which resulted in a statistically significant difference
experimental groups were not significantly different with between experimental groups (Figure 3).
respect to age (Figure 1).

Table 1: Mechanical testing data from unconfined compression of the cancellous bone cores
Bone Elastic Yield Ultimate Ultimate Post Yield
Yield Stress
Type Modulus Strain Stress Strain Strain*

[MPa] [MPa] [%] [MPa] [%] [%]

Arthritis 531±315 5.72±3.4 1.13±0.43 6.54±3.5 2.02±0.59 0.887±0.41

Fracture 344±283 3.98±2.5 1.30±0.71 4.29±2.6 1.71±0.79 0.411±0.12


*Denotes statistical significance (Student’s t-test, p<.05).

10
Figure 3. Comparison of post yield strain between hip osteoarthritis and femoral neck fracture groups. Results are
statistically significant (p<0.05).

AGE Quantification Discussion


Compared to cancellous bone cores from patients with Osteoarthritis (OA) and osteoporosis (OP) are the two most
degenerative hip disease, calculations for the content of common musculoskeletal disorders found in the elderly
NEG were nearly 12% higher in the hip fracture group population. Over the last thirty years, the prevailing theory
(Figure 4). This difference was not statistically significant. in the literature was that these two disease entities were
Upon further analysis, no significant difference was found mutually exclusive. This largely stemmed from work
between the NEG content in males and females, either by Foss and Byers which studied 140 patients with hip
within each group or across groups. fractures and found only 3 with radiographic evidence of
osteoarthritis10. The prevailing opinion was that the pres-
ence of hip OA was protective against OP and helped to

Figure 4. AGE content was higher in the fracture group than in the osteoarthritis group, but this increase was not
statistically significant (p=0.52).
11
prevent osteoporotic hip fractures11. This inverse relation- of hip fractures compared to age- and gender- matched
ship has been called into question over the past decade, non-fractured controls18. Within the control group of
with studies suggesting an underappreciated number of their study, osteoarthritic cases were excluded. In our
patients with concomitant OA and OP, especially in the study, quantifiable AGE levels were found in cancellous
female, post-menopausal population. Glowacki et al. bone from both hip fracture and osteoarthritic patients.
found that 25% of a cohort of post-menopausal women While the amount of NEG we measured was not com-
with degenerative joint disease (DJD) scheduled for elec- pared against a cadaver control group, it is important to
tive total hip arthroplasty also had occult osteoporosis12. A acknowledge the inherent difficulties of controlling for age
more recent study by Mäkinen et al. saw that nearly 73% with the possibility of sub-clinical OA and OP acting as a
of their cohort of female patients with OA undergoing hip confounding variable. We have also shown previously in
replacement were either osteopenic or osteoporotic based our lab that increasing age has a significant positive effect
on bone mineral density13. Our study attempts to better on the accumulation of AGEs in cortical and cancellous
understand both the biomechanics and biochemistry of bone7.8. It is thus important that the experimental groups in
cancellous bone samples taken from patients at the clini- this study were of similar ages (p= 0.26) in order to make
cal endpoint of these two disorders. The phenomenon of a fair assessment of NEG in each separate disease cohort.
NEG has already been shown in our lab to increase with Also, in order to eliminate the possibility of any poorly
age and results in a decrease in the mechanical proper- controlled diabetic patients affecting the AGE content of
ties of bone8. These resulting advanced glycation end the cancellous bone, HbA1c levels were found to be similar
products have been implicated as a pathogenic factor between experimental groups. Overall, there was indeed
in a variety of diseases, including the articular cartilage a slight trend in our data towards more AGEs in the hip
degeneration seen in osteoarthritis14. To our knowledge, fracture group by 12%. Although this difference was
this is only the second study to examine the NEG process not statistically significant, it is possible that an increase
in patients with fractured cancellous bone and the first in sample size may yield results to support our original
study to quantify AGE levels in the underlying bone of hypothesis. The increase in NEG also helps to explain the
osteoarthritic patients. fact that under compression the fractured bone was found
Other studies have performed mechanical testing to behave in a significantly more brittle manner than the
on both osteoporotic and osteoarthritic bone. The values osteoarthritic bone, especially considering our previous
for elastic modulus in our study revealed a 36% increase work that has shown NEG to have detrimental effects on
in stiffness for the OA bone. Although the result is not the post-yield properties of cancellous bone8.
statistically significant, this trend is consistent with work At a minimum, it cannot be discounted that
done by Li and Aspen, who compared subchondral and this study demonstrates that the phenomenon of NEG is
cancellous bone samples in OA and OP hips to age- and occurring in the cancellous bone collagenous matrix of
gender- matched controls and demonstrated an increase both osteoarthritic and osteoporotic patients and may be
in stiffness for the OA group compared to OP15,16. These contributing in different ways to these disease processes.
results support the idea that the underlying bone indeed Whether the mechanical alterations found in arthritic
plays some role in the pathogenesis of OA. In a recent bone in our study are primary or secondary to degenera-
report, Sun et al. compared seven femoral heads taken tive changes in the overlying cartilage, and whether the
from fractured hips with seven femoral heads from total accumulation of AGEs, which is known to occur at the
hip replacements due to degenerative joint disease 17. articular surface, also affects the NEG process within
Also lacking a control group, they found a significantly bone warrants future research. If further data collection
higher elastic modulus and yield stress in the osteoarthritic shows a significant increase in AGE levels in osteoporotic
bone. Unlike our study, Sun et al. did not examine post- patients compared to others of similar ages, then we may
yield properties, which are clinically more relevant when have another target in the treatment of osteoporosis and
determining the toughness of bone. They postulated the the prevention of fragility fractures. Recent advances in
increase in stiffness and yield stress may explain why pharmaceutical research proposing “AGE inhibitors” and
several aforementioned epidemiological reports have “AGE breakers” offer much potential promise as addi-
shown fractures to be rare in the OA population. The data tional weapons against the increasing health care burden
in our study reveals a significant reduction in post-yield of osteoporotic hip fractures.
strain in the fracture group, supporting our hypothesis
that the fractured bone would undergo less compression Acknowledgements
prior to failure. This work was supported by NIH grant AG20618. Thanks
Saito et al. reported an increase in advanced gly- to Howie Morris of Albany Medical Center in the Depart-
cation end products (AGE) within cancellous bone in cases ment of Radiology for assistance with the x-rays.

12
References

1. Johnell O, Kanis J. Epidemiology of osteoporotic 11. Cumming RG, Klineberg RJ. Epidemiological
fractures. Osteoporos Int. 2005; 16: S3-S7. study of the relation between arthritis of the hip and hip
fractures. Annals of Rheumatic Diseases. 1993;52:707-
2. Sernbo I, Johnell O. Consequences of a hip frac-
710.
ture: a prospective study over 1 year. Osteoporos Int.
1993;3:148-153. 12. Glowacki J, Hurwitz S, Thornhill TS, Kelly M,
LeBoff MS. Osteoporosis and vitamin-D deficiency
3. Einhorn TA. Metabolic Bone Disease. In: Einhorn
among postmenopausal women with osteoarthritis
TA, O’Keefe RJ, Buckwalter JA, editors. Orthopaedic
undergoing total hip arthroplasty. J Bone Jt Surg, Am.
Basic Science. Rosemont: American Academy of
2003; 85:2371-2377.
Orthopaedic Surgeons; 2007; p 415-426.
13. Mäkinen TJ, Alm JJ, Laine H, Svedström E, Aro
4. Viguet-Carrin S, Garnero P, Delmas PD. The
HT. The incidence of osteopenia and osteoporosis in
role of collagen in bone strength. Osteoporos Int.
women with hip osteoarthritis scheduled for cementless
2006;17:319-336.
total joint replacement. Bone. 2007;40:1041-1047.
5. DeGroot J. The AGE of the matrix: chemistry, con-
14. Verzijl N, Bank RA, TeKoppele JM, DeGroot J.
sequence and cure. Current Opinion in Pharmacology.
AGEing and osteoarthritis: a different perspective.
2004;4:301-305.
Current Opinion in Rheumatology. 2003;15:616-622.
6. Wang X, Shen X, Li X, Mauli Agrawal C. Age-
15. Li B, Aspden RM. Mechanical and material proper-
related changes in the collagen network and toughness
ties of the subchondral plate from the femoral head of
of bone. Bone. 2002;31:1-7.
patients with osteoarthritis and osteoporosis. Annals of
7. Vashishth D, Gibson GJ, Khoury JI, Schaffler MB, Rheumatic Diseases. 1997;56:247-254.
Kimura J, Fyhrie DP. Influence of nonenzymatic glyca-
16. Li B, Aspden RM. Composition and mechanical
tion on biomechanical properties of cortical bone. Bone.
properties of cancellous bone from the femoral head of
2001; 28:195-201.
patients with osteoporosis or osteoarthritis. Journal of
8. Tang SY, Zeenath U, Vashishth D. Effects of non- Bone and Mineral Research. 1997;12: 641-651.
enzymatic glycation on cancellous bone fragility. Bone.
17. Sun S, Ma H, Liu C, Huang C, Cheng C, Wei H.
2007;40:1144-1151.
Difference in femoral head and neck material proper-
9. Bostrom MPG. Bone metabolism and metabolic ties between osteoarthritis and osteoporosis. J Clin
bone disease. Orthopaedic Knowledge Update 9. Rose- Biomech. 2008.
mont: American Academy of Orthopaedic Surgeons;
18. Saito M, Fujii K, Marumo K. Degree of mineral-
2008:189-196.
ization-related collagen crosslinking in the femoral neck
10. Foss MV, Byers PD. Bone density, osteoathrosis cancellous bone in cases of hip fracture and controls.
of the hip, and fracture of the upper end of the femur. Calcif Tissue Int. 2006;79:160-168.
Ann Rheum Dis. 1972;31:259-264.

13
How Much Motion is There in the Normal Scapholunate Joint?
Richard L. Uhl, MD*, Mitchell Campito, MD±, Miguel Perela-Cruz, MDß
*
Division of Orthopaedic Surgery, Albany Medical College, Albany, NY
±
Department of Radiology, Albany Medical Center, Albany, NY
ß
Department of Orthopaedics, Wichita Clinic, Wichita, KS

This study was undertaken to evaluate motion which occurs in the normal scapholunate joint, as the wrist moves
from extension to flexion, and to compare that motion to the radiocarpal (radiolunate) and midcarpal (lunocapi-
tate) motion occurring at the same time. We found that there was an average of 32 degrees of motion at the
scapholunate joint. This represented 52% of the midcarpal motion, with 29 degrees of scaphocapitate motion
accounting for the remaining 48% of midcarpal motion. Midcarpal motion averaged 54% of total wrist motion,
thus for each 4 degrees of wrist motion, approximately 2 degrees occurred at the midcarpal joint, with 1 degree of
motion occurring at the scapholunate joint. Motion outside the range described may indicate wrist pathology.
Introduction Materials and Methods
The scaphoid plays a unique role in carpal mechanics, act- Thirty volunteers, without wrist problems, had plain lateral
ing as a linkage to stabilize the midcarpal joint.1,5 Although X-rays taken with their wrists in extension, neutral and
reports of the ratio of radiocarpal to midcarpal motion vary, flexion (Figure 1). Each was asked to hold their wrist in
both joints contribute to total wrist motion. 3,4,6,7 Since the maximum extension and flexion; no attempt to passively
scaphoid is attached by ligaments to both the lunate and bend the wrist further was made. Each wrist was care-
capitate, the scapholunate and scaphocapitate joints each fully positioned with the radius and ulna superimposed to
must contribute to the total midcarpal motion. In this study minimize variation.
we used plain X-rays to evaluate the normal motion of the The X-rays were then digitized, at 150 dots per
scapholunate, scaphocapitate, and lunocapitate joints while inch, 256 shades of gray, using a transilluminated radio-
the wrist moves from extension to flexion. graph scanner (XRS Company, San Jose, CA). During
scanning, the image was adjusted to compensate for
X-ray technique differences. The digitized images were
displayed on a high resolution computer monitor at 8 to
10X zoom. Computer software was used to adjust the
level (brightness) and window (contrast) of the images so
that the outlines of the overlapped carpal bones could be
clearly distinguished on the lateral X-ray (Image Systems,
Troy, NY).
Standard radiographic axes of the scaphoid, lu-
nate, capitate, and radius were plotted over the digitized
X-ray image, using a computer assisted drafting (CAD)
program (Image Meterology, Ballston Spa, NY). 2,4,7.
Angles between each axis were measured using the CAD
program and recorded (Figures 2 and 3). The average
angle and standard deviation were determined for each
wrist position, and the motion and contribution to total
wrist motion for each joint calculated.

Results
Active wrist motion averaged 64 degrees extension and 50
degrees flexion, for a total active motion of 114 degrees
(+/- 22 degrees). The average midcarpal (lunocapitate)
motion was 61 degrees (+/- 18 degrees). This accounted
for 54% of the total wrist motion.
Figure 1. Lateral X-ray films with the wrist in extension
(top), neutral (middle), and flexion (bottom). Note the
change of position of the scaphoid relative to the lunate as
the wrist moves from extension to flexion.
14
Figure 2. Computer screen image with the wrist in ex- Figure 3. Computer screen image with the wrist in
tension, showing the axis of the lunate and axis of the flexion showing an increase in the angle between the
scaphoid. After the axes are drawn on the screen the scaphoid and lunate, indicating the normal motion in that
software calculates the angle between them. Additional joint.
axes are plotted for the radius and capitate, and the angles
between each measured.

The scapholunate angle changed from 37 degrees X-ray.4,7 Motion of the scaphoid also involves rotation
(+/- 10 degrees) in extension to 69 degrees (+/- 10 degrees) under the capitate, which cannot be adequately analyzed
in flexion. The scaphocapitate angle changed from 72 by this simple method.
degrees (+/- 8 degrees) in extension to 43 degrees (+/- 12 Based on the data presented, for every 4 degrees
degrees in flexion). of wrist motion, there is approximately 2 degrees of
The 32 degrees of scapholunate motion accounted midcarpal motion, and approximately 1 degree of motion
for 52% of the total midcarpal motion. The 29 degrees of at the scapholunate joint. Any efforts to reconstruct the
scaphocapitate motion accounted for the remaining 48% scapholunate joint must allow a similar degree of motion or
of midcarpal motion. midcarpal stiffness will result.3 Fusion of the scaphocapi-
Fifty-five of the average 64 degrees of extension tate joint will eliminate approximately 50% of midcarpal
occurred at the midcarpal joint, however individual varia- and 25% of total wrist motion. Ligament reconstruction
tion was wide from 17 percent to 76 percent. Likewise, that allows motion at the scapholunate joint may help to
of the 50 degrees of average flexion, 48% occurred at the increase the resulting motion.
midcarpal joint, but again, individual variation was wide Motion at the midcarpal joint varied considerably
(14% to 80%). among the volunteers, which may account for the wide
variation of the contribution of this joint in previously pub-
Discussion lished reports.4,7 Motion outside the range described may
Wrist motion is the result of complex 3-dimensional mo- indicate pathology, but, for evaluation of the individual
tion of the carpal bones as they interact with each other 6. patient, comparison views my be needed to determine
While the scaphoid stabilizes the midcarpal joint, it also normal for that patient, rather than using a published
allows midcarpal motion. This study examines only the range of values.
motion of flexion and extension as it projects on the lateral

References
1. Bereger RH, Blair WF, Crowninshield RD, Flatt AE. 2. Destouet JM, Gilula LA, Reinus WR. Roentgeno-
The scapholunate ligament. J Hand Surg. 1982;7:87- graphic diagnosis of wrist pain and instability. In: Licht-
91. man DM, ed. The wrist and its disorders. Philadelphia:
WB Saunders, 1988;82-95.

15
3. Gellman H, Kauffman D, Lenihan M, Botte MJ, 6. Ruby LK, Cooney WP, An KN, Linscheid RL, Chao
Sarmiento A. An in vitro analysis of wrist motion: The EYS. Relative motion of selected carpal bones. A
effect of limited intercarpal arthrodesis and the contribu- kinematic analysis of the normal wrist. J Hand Surg.
tions of the radiocarpal and midcarpal joints. J Hand 1988;13A:1-10.
Surg. 1988; 13A:390-5.
7. Schuhl JF, Leroy B, Comtet JJ. Biodynamics of the
4. Larsen CF, Mathiesen FK, Lindequist S. Measure- wrist: Radiologic approach to scapholunate instability.
ments of carpal bone angles on lateral wrist radiographs. J Hand Surg. 1985;10A:1006-8.
J Hand Surg. 1991; 16A:888-93.

5. Ruby LK, An KN, Linscheid RL, Cooney WP 3d,


Chao EY. The effect of scapholunate ligament section
on scapholunate motion. J Hand Surg. 1987;5A:767-
71.

16
Displaced Intra-articular Calcaneal Fractures Comparison of Two Different Surgical Techniques:
Modified Palmer’s Approach and Extensile Lateral Approach: Early Complications,
Radiographic Findings and Outcomes
Camilo Guzman, MD, Paul Hospodar, MD, John DiPreta, MD, Paul Johnson, MD
Division of Orthopaedic Surgery, Albany Medical College, Albany, New York

Presented at the 2009 AMC Orthopaedic Surgery Annual Resident Thesis Day

Background: Intra-articular calcaneal fractures remain a challenging group of injuries to manage. Recent studies
have suggested operative intervention provides advantages over non-operative treatment, albeit with an increased
risk of wound complications. Varying surgical approaches have been advocated, and selecting one which minimiz-
es the risk to the soft-tissue envelope would provide a significant advantage in maximizing the patient’s post-op-
erative outcome. This study was undertaken to examine the differences in radiographic and functional outcomes,
as well as in rates of soft-tissue complications associated with intra-articular calcaneal fractures treated surgically
using either an extensile lateral or a modified Palmer’s approach.

Methods: We retrospectively reviewed surgically treated calcaneal fractures treated at a level I trauma center
over a period of 4.5 years. Twenty-two fractures were treated with a modified Palmer’s approach and 52 fractures
were treated with an extensile lateral approach. Functional outcomes were evaluated using the AAOS foot and
ankle questionnaire administered at office visits or by telephone interviews.

Results: Sixty-eight patients with 74 displaced intra-articular fractures, were followed for an average of 20
months. The population skewed predominantly male (76%; p<0.001). Mean age at time of injury was found to be
38.5 years (range, 15 to 70) with no significant differences noted between the extensile lateral and the modified
Palmer groups. The single largest mechanism of injury was fall from height (66.7%) with motor vehicle accident
the second most common (25.3%). Severity of initial injury, as evaluated by Sander’s classification, was not found
to be significantly different between groups. Two patients (9%) treated with the modified Palmer’s approach
developed wound complications that were successfully managed with wound care, while 24 patients (46%) treated
with the extensile lateral approach developed wound complications.

Conclusions: There was no significant difference in outcomes between the two groups. Our data would support
a decrease in the rate of wound complications associated with a modified Palmer’s approach as compared to the
extensile lateral approach without a significant change in the patient’s functional outcome or in the degree of
radiographic improvement.
Introduction popularized by Palmer10 in 1948. However, inability to
Calcaneal fractures account for 60% of fractures of the reproduce Palmer’s results led to a decline in the use of
tarsal bones and 2% of all fractures1,2. These fractures can this method.
be classified broadly into intra-articular and extra-articular During the last decade there has been renewed
types, with the intra-articular variant being more common, enthusiasm for the operative treatment of intra-articular
representing 70-75% of all fractures of the os calcis, fre- calcaneal fractures. Thordarson11, in a prospective, ran-
quently resulting from axial loading with varying degrees domized study comparing operative and nonoperative
of shear force3. Despite their frequency, advances in di- treatment of calcaneal fractures, found that functional
agnostic imaging and methods of internal fixation, their scores were better for fractures treated surgically than for
management remains challenging and controversial8. those managed by nonoperative methods. Buckley7, in
Treatment goals focus on the minimization of another prospective study, demonstrated similar results,
pain and the maximization of functional use of the foot but in a select group of patients. The meta-analysis by
in performance of activities of daily living. Current rec- Randle et al. 12 also reported a tendency for better results
ommendations for treatment range from nonoperative to with operative treatment.
operative intervention4,5,6,7, including primary arthrodesis, There remains, however, no consensus regarding
closed reduction and percutaneous pinning, and open the surgical approach, with many having been described,
reduction with internal fixation (ORIF). Open technique including medial, lateral, combined medial and lateral,
was described by Lenormant and Wilmoth9 in 1932 and extended lateral, and sinus tarsi approaches. Further, the
17
method of fixation remains a point of debate, with various fibula and roughly perpendicular to the long axis of the
proponents advocating fixation with pins, screws, or plate fibula. The incision starts approximately 1 cm posterior to
fixation with screws2,6,8,29,30,33,35,36,37,39,40. the fibula and continues distally for a total length of 3 to 4
While the literature suggests significant benefit cm. The incision is more transverse than that used by Palm-
from operative management of these fractures, complica- er. We have found that this technique facilitates excellent
tions have been shown to be a common problem in many visualization of the posterior facet. The peroneal tendons
studies, with some series reporting up to 33% incidence are identified and the distal portion of the retinaculum is
of surgical wound breakdown13,14,15,16,17,18,19,20, a finding that released. The tendons are mobilized and retracted anteri-
has prompted interest in minimally invasive techniques, orly. The fat pad in the sinus tarsi is mobilized proximal to
including the use of a modified Palmer’s approach, that distal, and the capsule of the posterior talocalcaneal joint is
offer the potential to avoid compromising the already opened if the capsule is intact. An elevator is used to align
damaged soft tissue envelope. the posterior facet with the medial sustentaculum fragment,
The purpose of this study was to review differ- and the depressed posterior facet is reduced to the talus.
ences in outcomes and early wound complication between Kirschner wires are used to provisionally fix the posterior
patients with intra-articular calcaneal fractures treated facet to the medial fragment, and one or two lag screws
with a modified Palmer’s approach and the extensile are passed across the fracture site from lateral to medial.
lateral approach. Once this posterior facet fragment is fixed to the medial
fragment and the joint has been successfully elevated,
Materials and Methods correction of the varus deformity of the posterior tuberos-
A retrospective review was done of all calcaneal fractures ity is performed. A Schantz pin is inserted into the lateral
treated at a level I trauma center over a period of 4.5 years. aspect of the calcaneus tuberosity. This pin is then pulled
This study was given full approval from the local Institu- downward to recreate the calcaneal height and to correct
tional Review Board and ethics committee. the varus alignment. Often a laminar spreader is placed
Inclusion criteria for the entry into the study between the tuberosity and posterior facet fragments to
consisted of adult patients older than 17 years of age, with help maintain height. K-wires are then passed from the
a diagnosis of displaced intra-articular calcaneal fractures heel into the posterior facet fragment to provisionally
treated surgically, and with fractures meeting Sanders II stabilize the tuberosity fragment. A 6.5 cannulated screw
classification or greater, as defined by the findings in the is used to complete the fixation. Finally, bone grafting of
CT scan. Patient selection was restricted to those treated the defect below the posterior facet is performed by either
by either a trauma surgeon or an orthopaedic foot special- bone grafting with cancellous bone chips or with calcium
ist. Patient with concomitant injuries to the ipsilateral foot pyrophosphate bone cement. The wound is irrigated prior
were excluded. to closure and closed with deep 2-0 absorbable sutures.
Between Sept 2002 and April 2007, 72 patients Skin closure is performed with 4-0 nylon sutures
with 78 intra-articular calcaneal fractures underwent sur-
gical management. Four patients were excluded because Extensile Lateral Approach: Described by Benirschke et
a primary fusion was done at the time of the initial treat- al.15, a modification of the techniques described by Palmer
ment. This resulted in a study population of 74 displaced and Letournel was used. This is an extensile, L-shaped
intra-articular fractures of the os calci in 68 patients. The lateral incision. The vertical part of the incision paral-
patients were divided into two groups: Group 1 consisted lels the long axis of the limb, the horizontal part roughly
of 22 fractures that were treated with the sinus tarsi ap- parallels the plantar surface of the foot. A full thickness
proach; Group 2 included 52 fractures treated with the flap is raised containing the peroneal tendons, sural nerve
extended lateral approach. Patients were initially treated and calcaneofibular ligament. This exposure allows vi-
with ice and elevation. Timing for the surgical interven- sualization from the tuberosity to the calcaneo-cuboid
tion was delayed until soft tissue swelling had adequately joint. Kirschner wires are placed in the fibula, talar neck
subsided and skin wrinkling was apparent. and cuboid. These are bent to minimize retraction on the
wound edges, using a so-called “no touch” technique.
Operative Technique Fracture reduction is initiated with elevation of the ex-
All the patients in this study underwent open reduction and panded lateral wall, disimpaction of the posterior facet
internal fixation through either an extensile lateral or sinus and lag screw fixation of the facet to the sustentacular
tarsi approach, which are described in detail below. segment. The tuberosity malalignment is then corrected,
as is the height. Provisional K wire fixation is utilized.
Modified Palmer Lateral (Sinus Tarsi) Approach20: In this Fluoroscopic imaging with lateral, axial and Broden’s
approach, a straight incision is made on the lateral side of projection are analyzed to assess reduction. Plate fixation
the foot, approximately 1 to 1.5 cm distal to the tip of the is then applied in the tuberosity, beneath the posterior facet
18
and along the anterior calcaneus. The surgical wound is divided into the same groups used for the Maryland Foot
closed over an eighth-inch Hemovac drain. Wound closure and Ankle score (MFS): a score of 90-100 was graded as
is accomplished with inverted 2-0 absorbable sutures to an excellent result; 75-89 as good; 50-74 as fair, and less
close the subcutaneous layer and 3-0 nylon horizontal than 49 was graded as a failure. Patients were evaluated
mattress sutures for the skin. during an office visit, or by telephone interview.

Post-Operative Management Results


Postoperatively the management for the two groups was Sixty-eight patients with 74 displaced intra-articular cal-
similar; the patients were placed in a ‘bulky Jones’ dress- caneal fractures treated surgically were registered in the
ing with the extremity elevated for 48 hours. Intravenous study. Patients were followed on average for 20 months.
antibiotics were continued for 24-48 hours. When the There were 50 (74%) men and 18 (26%) women (p<0.001).
soft tissue swelling had abated, the patient was allowed The age of the patients at the time of injury was a mean of
to begin active range of motion of the ankle and subtalar 39 (range, 15 to 70) (Table 1). Twenty-five fractures (33%)
joints. Walking on the injured foot was not permitted for were due to polytrauma and fifty (67%) fractures due to
twelve weeks. Resumption of weight-bearing was initiated isolated trauma. The trauma mechanism was a motor
at that time to patient tolerance. Individuals with unilateral vehicle accident in 19 fractures (25.3%), fall from height
fractures were instructed to bear weight on the forefoot ini- represented 50 fractures (66.7%), and 6 (8%) fractures
tially, with gradual resumption of heel-to-toe ambulation. were the result of other type of mechanism.
For the group treated with the modified Palmer’s approach, No significant differences between the groups
25% weight bearing was allowed at eight weeks, which treated with the modified Palmer’s approach (Group 1)
was incremented by 25% for every week thereafter, by and extensile lateral approach (Group 2) were detected
twelve weeks the patient was full weight bearing. with regard to the age at the time of injury, mechanism of
Medical records and radiographs were retrospec- injuries, or type of fracture classifications. Any wound
tively reviewed. Wound complications were defined using that did not heal primarily, required dressing changes,
clinical criteria, specifically persistent drainage, inflam- local wound care, further surgery, became infected with
matory signs, events requiring unplanned procedure (i.e. discharge, exhibited any signs of skin necrosis, or that
debridement), need for additional special wound care and required antibiotics was recorded as wound complication
patients requiring treatment with antibiotics beyond two (Table 2). Two patients (9%) of Group 1 developed wound
weeks postoperatively. complications, compared to twenty-four patients (46%) in
Group 2.
Radiographic Data Further description of this subgroup of patients
The preoperative radiograph and computer tomography was performed, examining these patients for additional
(CT) scans were used to evaluate and classify the fracture. factors such as smoking history and diabetes. In the uni-
All patients had displacement greater than 2mm from variate analysis, there were seven smokers in Group 1, one
anatomic position. Sander’s classification8,31, without diabetic, four worker’s compensation patients, and two
subclasses, was utilized in order to describe the fracture. patients who experienced some type of wound problem.
Lateral radiographs immediately after the surgery and In Group 2, there were nineteen smokers, eight
during the last clinic follow-up visit were also evaluated. diabetics, twelve patients with worker’s compensation,
The angles of Gissane and Böhler, as measured on these and twenty-four who experienced some type of wound
three sets of radiographs, were compared. problem. Of note, all surgical wounds healed and no major
complications, such as deep infections or amputations,
Functional Outcome were documented. Incision and drainage was required in
The AAOS foot and ankle questionnaire was used as a only three patients (5.7%) in Group 2, none in Group 1,
measure of functional outcome. This is a patient-reported, and no patients were noted to have developed osteomy-
foot-specific instrument. The questionnaire has twenty elitis. Using the Pearson’s Chi-Square, in Group 2 it was
items that, combined, form the Foot and Ankle Core shown that smoking was significantly related to wound
Scale and an additional five questions that form the Shoe problems (p=0.025), and diabetes trended towards, but was
Comfort Scale. The Core Scale can be further subdi- not significantly related to, wound problems (p=0.067).
vided into four subscales: Pain (nine items), Function In Group 2 smoking trended towards, but was not signifi-
(six items), Stiffness and Swelling (two items) and Giving cantly related to, wound problems (p=0.075).
Way (three items) 22. Patients with bilateral fracture were Four patients, one (4.5%) from Group 1 and three
asked to complete the questionnaire for the foot with the (5.6%) from Group 2 had hardware removal at the time of
most complaints and functional disability. For purposes most recent follow up. Removal of the hardware was car-
of comparison, the AAOS Foot and Ankle scores were ried out at the patient request, or if there was found to be
19
Table 1. Patient Demographics
  Modified Palmer’s Extensile Lateral
Total
Approach (Group 1) Approach (Group 2)
68 Patients
19 Patients 49 Patients
74 Fractures
22 Fractures 52 Fractures
Sex      
•    Male 50 (74%) 15 (79%) 35 (71%)
•    Female 18 (26%) 4 (21%) 14 (29%)
Age/mean (years) 38.5 (19-71) 36 (19-71) 41 (22-65)
Other Factors      
 Smoker 26 (38%) 7 (37%) 19 (39%)
 Diabetes 9 (13%) 1 (5%) 8 (16%)
Worker’s
16 (24%) 4 (21%) 12 (24%)
Compensation Injury
Wound Complications 26 (38%) 2 (11%) 24 (49%)

Table 2. Treatment of Wound Complications

  Modified Palmer’s Extensile Lateral


Approach (Group 1) Approach (Group 2)
  22 fractures 52 fractures
Wound Complications 2 (9%) 24 (46%)
I&D ----- 3 (5%)
Wound Care 2 (9%) 16 (30.7%)
Antibiotics Only ----- 5 (9.6%)

scar tethering and pain at the site of hardware insertion. No Discussion


significant difference was found between the two groups. Debate on the treatment of calcaneal fractures continues
Late fusion was performed in one (4.5%) patient from the despite numerous published series. Recent retrospective
sinus tarsi approach and in three (5.6%) from the lateral and small prospective studies have suggested that operative
extensile approach at the time of final follow-up. care of displaced intra-articular calcaneal fractures had an
Forty-four fractures (60%) were classified as advantage over non-operative care6,13,31,32,38,40. The largest
Sanders’s II, twenty-six (35%) as Sanders’s III and four prospective, randomized, multicenter study of Buckley et
(5%) as Sander’s IV. No significant difference was found al7 showed benefit of surgical over conservative treatment
between the groups (Table 3). Information on the Böhler’s in a selected number of patients, specifically those who are
angle was available for fifty-nine cases. There were no younger, female, have a light-to-moderate workload in-
differences between the two groups at the time of last volving the foot, and those who are not receiving Worker’s
follow-up (34° Group 1 vs. 31° Group 2) (Table 3). Compensation do well with operative care. Another study
Six patients had a bilateral injury; three in each suggests that patients treated operatively are 5.5 times less
group. Sixty-nine was the maximum possible number of likely to need a subtalar arthrodesis3.
recorded the AAOS foot and ankle scores. Eighty-four Open reduction procedures have the main ad-
percent of Group 1 subjects and seventy percent of Group vantage of an anatomic reduction, restoring the subtalar
2 subjects were able to answer the questionnaire. The four joint congruity, arch height, heel width and decreased
patients who had already undergone arthrodesis did not the possibility of lateral impingement. Proponents of this
complete the questionnaire and were considered to have approach emphasize that this anatomic restoration, with
a poor result from the primary treatment. The functional a limited period of immobilization, lead to superior func-
outcomes are presented in Table 4. In Group 1, 69% of tional results5,6,8,14,29.
patients had a good to excellent result compared to 66% Despite the high enthusiasm in recent years for
in Group 2. the operative treatment of intra-articular calcaneal frac-
tures, the soft tissue problems associated with it 15,16,17,18,19
20
Table 3. Radiographic Evaluation
  Modified Palmer’s Extensile Lateral
Total Cases
(Group 1) (Group 2)
Sander’s Classification      
Sanders II 44 (60%) 13 (59%) 31 (60%)
Sanders III 26 (35%) 6 (27%) 20 (38%)
Sanders IV 4 (5%) 3 (14%) 1 (2%)
Böhler’s Angle      
(mean ± SD)      
Initial   15.5° ± 16.5 12.4° ± 14.8
Immediate   36.8° ± 6 31.1° ± 7.8
Post-operative
Last Follow-up   34.1° ± 6.1 30.9° ± 8.2

has dismayed many authors. Additionally, there remains Wound complications have proven to be a prob-
poor consensus regarding the surgical approach to be used. lem: Stephenson et al. 11 report an incidence of wound
The literature describes a multitude of different approaches breakdown of 27% while Benirschke et al.15,17 report 11%
to the calcaneus, including lateral, medial, the combined rate of wound complications using the lateral approach.
lateral and medial approach, sinus tarsi and, currently the The high incidence of wound complications in our series
most popular, the extensile lateral approach6,11,13,20,21. may reflect the broad criteria that were used to define them.
The authors of this study propose that the use of a Our results should be carefully analyzed as the disparity
modified Palmer’s approach as treatment of intra-articular in wound complications between the two groups may
calcaneal fractures has the potential advantage of avoiding somehow be attributed to the difference in the number
compromise of the already damaged soft tissue coverage of patients (22 vs. 53), the disproportionate number of
on the lateral side. Since wound breakdown has the pos- ipsilateral injuries (9% vs. 21%) and number of patients
sibility of resulting in a more severe complication, such as that sustained other, significant musculoskeletal injuries
osteomyelitis or in some cases the need to perform flaps to (18% vs. 40%), (Group 1 modified Palmer’s approach
cover the soft tissue defect, and in extreme cases amputa- vs. Group 2 extensile lateral approach, respectively). Our
tion, it is very important to avoid this complication. analysis, however, suggests that there is no significant
Soft tissue complications in our series were less difference between patients with isolated injuries and
frequent for the group of patients treated with a modified polytrauma injury.
Palmer’s approach (Group 1) versus the extensile lateral Aktugle et al. 41, in a study of 36 displaced intra-
approach (Group 2), (9% vs 46% respectively). These articular calcaneal fractures, showed poorer outcomes for
rates approach those reported by Gupta et al.21 where the those patients who sustained polytrauma when compared
incidence of wound complications was noted to be 3% with patients with isolated injuries, independent of the type
in the treatment of 32 fractures treated with the modified of treatment chosen. This may be accounted for given the
Palmer’ approach. tendency for polytrauma patients to have been subject to
Table 4. Outcome according to AAOS foot and ankle score. Bilateral injuries were counted once. Patients who had
subtalar fusion after the initial treatment were considered poor outcome.

Modified Palmer’s Approach Extensile Lateral Approach


Number of patients evaluated
Group 1 Group 2
16 (84%) 35 (71%)
AAOS Score Average ± SD   82.6 ± 10.9   77.5 ± 14.9
•    Excellent 31% 20%
•    Good 38% 46%
•    Fair 25% 20%
•    Poor 6% 9%
21
higher energy mechanisms of trauma, and the understand- to decreased operative time and dissection required. The
ing that the additional injury to other systems, in addition modified Palmer’s approach is more distal to the lateral
to their significant orthopaedic injuries, leads to a major calcaneal artery and thus appears to avoid injury to this
catabolic response that has the potential for impairment artery, implicated as a cause of wound complications with
of soft tissue healing. the extended lateral approach. Smoking seems to be the
Radiographic findings demonstrated equivalent other only factor associated with wound complications.
improvement for the two groups, improving Böhler’s However, our results should be evaluated carefully. There
angle, restoring measured values to within a normal range. are limitations of our study. First, this is a retrospective
Because Group 1 subjects received only screw fixation review, and is limited accordingly. Secondly, the number
and bone graft or calcium pyrophosphate, there was a of patients treated in the extensile lateral approach outnum-
concern during follow-up that a loss of reduction might ber those treated with the modified Palmer’s approach by
result, due to the poorer biomechanical advantages of this a ratio of 2:1. This disparity may have limited the ability
type of fixation as compared to the use of plate and screw of this study to clearly identify significant differences.
fixation. Our data demonstrate that at the time of final Thirdly, we have used broad criteria to define wound
radiographic evaluation there was no evidence of further complications. In our series only three patients (5.7%) had
collapse or change in Böhler’s angle. These findings are a severe infection that required additional intervention and
in line with those reported by Gupta et al. 21, where the no patient required reconstruction with a flap, was diag-
use of the modified Palmer lateral approach, demonstrated nosed with osteomyelitis, or required amputation. These
significant improvement in mean values of Böhler’s angle, findings are closer to what has been published in the recent
posterior facet angle, posterior facet depression, heel width literature. Of all the patients treated in our institution with
and calcaneal height on CT scans post-operatively. the diagnosis of intra-articular calcaneal fracture, only one
At last follow-up the American Orthopaedic Foot required reconstruction with a flap, and of note, this patient
and Ankle score was classified as good to excellent in 66% had initially been treated at another institution.
to 69%, with no difference found between groups. The We conclude that both techniques are equally suc-
rate of late fusion similarly showed no difference and its cessful at improving radiographic parameters. Outcomes
incidence was found to be similar to what has described were similar for the two groups. Although there was a
in the literature. Buckley et al. 3 found that the need for difference in the rate of wound complications, there was
arthrodesis was 4% in a series of patients treated with no significant difference in the incidence of severe com-
ORIF. Csizy et al. 3 in a review of a prospective randomized plications. There is a learning curve for both techniques.
database, found a subtalar fusion rate of 9.8%. In our study the surgical intervention was performed by
In summary, this retrospective review study either an orthopaedic foot specialist or a trauma specialist,
comparing two different techniques for the treatment of and at least one study has suggested there is a significant
intra-articular calcaneal fractures found similar results relationship between the deep infection rate, traumatic
in outcome measures and improvement of radiographic subtalar arthritis and the institutional fracture load42.
criteria. However, a lower rate of wound complications Smoking seems to be the only other factor associated with
was observed with the group of patients treated with the wound complications.
modified Palmer’s approach. Differences may be attributed

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24
Comparison of Endoscopic and Open Carpal Tunnel Release in the Same Patient
Ali Hashemi, MD, Richard Whipple, MD, Erin L. Kaufman, MPH
Division of Orthopaedic Surgery, Albany Medical College, Albany, New York

Presented at the 2009 AMC Orthopaedic Surgery Annual Resident Thesis Day

Background: Considerable debate still exists over whether endoscopic carpal tunnel release is superior to con-
ventional open carpal tunnel release. The aim of this study is to retrospectively review a set of patients who have
had bilateral carpal tunnel surgery, open on one hand and endoscopic on the other hand, and look at their overall
function, satisfaction and return to activities.

Methods: Of 550 endoscopic releases done from December 2003 to October 2008, 33 patients had had previous
open carpal tunnel releases performed in the opposite hand prior to the endoscopic release. Of these 33 patients,
22 patients were evaluated for this study.

Results: Seventeen of 22 patients enrolled in this study had the initial (open) procedure performed in the domi-
nant hand. The average return to ADLs (Activities of Daily Living) and work was shorter for the endoscopic pro-
cedure. There were no wound healing problems noted with either procedure. There were no significant differences
in grip strength or pinch strength in the 2 groups. DASH (Disabilities of the Arm, Shoulder and Hand) scores
were also similar in both groups. Twenty of the 22 patients surveyed would recommend endoscopic surgery over
open carpal tunnel surgery to a family member or friend.

Conclusions: Patients who have undergone bilateral carpal tunnel surgery with one side done endoscopically
and one side open greatly favor the endoscopic surgery side from an overall satisfaction standpoint. This study
supports previous prospective studies that demonstrate faster short term return of function in the endoscopic group
compared to the open group.
Introduction Each patient had undergone an open carpal tunnel re-
Median nerve compression at the wrist is the most common lease on one hand and a one incision endoscopic release
compression neuropathy of the upper extremity. Annu- on the other hand. The results of this study showed no
ally, an estimated 1 million American adults have CTS advantage of the endoscopic release over open release in
requiring carpal tunnel release. The cost of this has been terms of patient satisfaction and return to normal function.
estimated to be over 2 billion dollars per year.1 Median Trumble et al in 2002 did a prospective randomized study
nerve compression at the wrist was first described by Sir of 192 hands in 147 patients comparing the single incision
James Paget in 1854 following a distal radius fracture.2 In endoscopic release and the open release.9 The study found
1880 James Putnam described the first series of patients that good functional outcomes and patient satisfaction are
with classical carpal tunnel symptoms with pain and achieved more quickly in the endoscopic group of patients.
paresthesia in the median nerve distribution of the hand.3 This study also found that there was no significant cost
The first carpal tunnel release was reportedly performed by difference in the two procedures.
Herbert Galloway in 1924.4 Endoscopic techniques were The purpose of this study is to evaluate patients
introduced to reduce the length of incision thereby decreas- who have had bilateral carpal tunnel surgery with one
ing postoperative pain. There is still considerable debate side done endoscopically and the other open. Complica-
over the efficacy of endoscopic carpal tunnel versus open tions, resolution time of symptoms, DASH scores, grip
in regards to postoperative morbidity and complications. strength, pinch strength, length of time to return to ADLs
The first endoscopic carpal tunnel release was performed and work and overall patient satisfaction will be recorded
by Okutsu et al in 1987 in Japan.5 The 2 portal endoscopic for these patients.
technique was introduced by Chow in 1989 and the one
incision was described by Agee in 1992.6,7 Several studies Materials and Methods
have been performed in order to compare endoscopic and In order to qualify for this study a patient would have
open carpal tunnel release but controversy still exists over bilateral carpal tunnel surgery, one which was performed
which procedure is superior. One study in the British JBJS open (by various surgeons) and one which was performed
by Ferdinand et al in 2002 was a prospective randomized via a single incision endoscopic technique by a single sur-
study of patients with bilateral carpal tunnel syndrome.8 geon (R.W). Patients that had any type of revision surgery
25
were disqualified. Prior to chart review, IRB approval was the open side averaged 13 visits. The average length of
obtained for the study. Overall, 550 patients qualified for the endoscopic scar was .94 cm, and the average length of
chart review. Of these, 33 qualified for the study. Of these scar for the open side was 3.3 cm. There were no wound
33, only 22 could be included either because of refusal to healing complications in either group.
enroll in the study or inability to contact patient. There were 6 cutaneous nerve complications
Prior to examining the patient, the examiner was as defined by a patch area of numbness over or near the
not told which hand was done endoscopically. Each patient thenar eminence. Three of these were endoscopic and
was examined for: grip strength, tip pinch and key pinch the other three were from the open group. Six patients
strength, 2 point discrimination, carpal tunnel provocative reported residual paresthesias in their hands, five of these
testing (Tinel’s, Phalen’s, Compression), abductor pol- were in the open group. Of the 4 hands that had weak-
licis brevis strength, numbness in the palmar cutaneous ness in APB testing, 2 were endoscopic and 2 were open.
branch distribution, and scar length. Grip strength was Of the 4 hands that failed 2-point discrimination testing,
measured using a Jamar dynamometer. Pinch strength was 2 were endoscopic and 2 were open. During provocative
measured using a pinch gauge. Abductor pollicis brevis testing, 5 of the open procedure hands recreated symptoms
strength was determined to be strong or weak based on of carpal tunnel syndrome and 4 of the endoscopic hands
exam and relative to the contralateral side. Pillar pain was exhibited signs of carpal tunnel syndrome. Ten patients
also recorded for each patient. When there was a radial demonstrated symptoms of pillar pain. Of these, 7 hands
sided pillar pain, thumb CMC testing and extensor ten- were done endoscopically.
don tenosynovitis testing was performed to rule out these When patients were asked which surgery they
pathologies. Range of motion deficits for each hand and would recommend for a family member or friend, 20 of
wrist were also documented. 22 patients recommended the endoscopic surgery. The
Each patient was asked to rank, on a scale of most common response for why was that it was a faster
1-5, their impression of each side. Patients also noted the recovery, less pain and a smaller scar.
time it took to return to work and return to ADLs after
each surgery. The total number of postoperative visits to Discussion
physical therapy were recorded for each patient. Patients From the results of this study it appears that the single
were also asked if they had any residual symptoms such incision endoscopic carpal tunnel surgery offers a shorter
as numbness, weakness, scar tenderness, swelling, and recovery time and better overall satisfaction for the patient
loss of coordination on each side using a 0-5 scale. The when compared to conventional open carpal tunnel release.
time to resolution of symptoms such as numbness, palm While the short term results appear to be improved for the
tenderness, and hand weakness was also recorded for endoscopic group, the data does not appear to demonstrate
each hand. Finally, the patients filled out a DASH form that the long term results of these two techniques are any
for each extremity. different as evidenced by similar motor strengths and
DASH scores. This study offers a unique perspective
Results for the patient and the examiner when comparing both
Of the 22 open procedures, 17 were done on the dominant hands. Furthermore there does not seem to be a significant
hand. Of the 22 endoscopic procedures, 5 were done on increase in complications associated with either surgery
the dominant hand. There was a mean of 9 years between in this particular study.
open and endoscopic surgeries. The average return to work There are several limitations to this study. This is
for the endoscopic side was 21 days and for the open side it not a randomized, prospective study with a large number
was 25 days (p value =.195). The average return to ADLs of patients which certainly can question the statistical sig-
for the endoscopic side was 15 days, and for the open side nificance of the results. While the endoscopic surgery was
34 days (p value<.001). The average DASH score for the done by a single surgeon, the open sides were done by vari-
endoscopic side was 20 and for the open side it was 16 (p ous surgeons with different surgical training (Neurosur-
value =.665). Mean grip strength for the endoscopic side gery, Orthopaedic Surgery, and Plastic surgery). Moreover
was 21 and for the open side 20 kg (p value =.61). there may have been bias in the endoscopic group. These
Seventeen of the 22 patients had comorbid patients may have selected the endoscopic procedure after
conditions such as diabetes (3 patients), thyroid disease their open procedure because of their level of dissatisfac-
(6 patients), hypertension (4 patients), and other medical tion with their previous surgeon. Another source of bias
comorbidities (4 patients). One patient had a cervical in this study is the fact that more open procedures were
spine fusion after her carpal tunnel surgeries. She stated done on the dominant hand of the patient. In this scenario
that her median nerve symptoms had resolved after each the patient is more likely to use the dominant hand more
hand procedure. Of the patients that went to physical compared to the non-dominant, which could delay the
therapy, the endoscopic group averaged 7 total visits, and recovery time compared to the endoscopic side.
26
References

1. Palmer DH, Hanrahan LP. Social and economic- 6. Chow JC. Endoscopic release of the carpal ligament:
cocosts of carpal tunnel surgery. Instr Course Lect. a new technique for carpal tunnel syndrome. Arthros-
1995;44:167-72. copy. 1989;5(1):19-24.

2. Paget J.  Lectures on surgical pathology.  Philadel- 7. Agee JM, McCarroll HR, Jr., Tortosa RD, Berry DA,
phia, Pa:  Lindsay and Blakiston;  1854. Szabo RM, Peimer CA. Endoscopic release of the carpal
tunnel: a randomized prospective multicenter study. J
3. Marie P, Foix C.  Atrophie isolee de l’eminence
Hand Surg Am. 1992;17(6):987-95.
thenar d’origine nevritique: role du ligament annulaire
anterieur du carpe dans la pathogenie de la leion.  Revue 8. Ferdinand RD, MacLean JGB. Endoscopic versus
Neurology (Paris).  1913;26:647-9. open carpal tunnel release in bilateral carpal tunnel
syndrome: a prospective, randomized, blinded assess-
4. Amadio PC. The first carpal tunnel release? J Hand
ment. JBJS Br April 2002.
Surg Br 1995;20(1):40.
9. Trumble TE, Diao E, Abrams RA, Gilbert-Anderson
5. Okutsu I, Ninomiya S, Takatori Y, Ugawa Y. En-
MM. Single-portal endoscopic carpal tunnel release
doscopic management of carpal tunnel syndrome.
compared with open release: a prospective, randomized
Arthroscopy. 1989;5(1):11-8.
trial. JBJS July 2002.

27
Total Shoulder Arthroplasty vs. Hemiarthroplasty for Osteoarthritis:
A Retrospective Review of Clinical Outcomes
Brent Carlson, MD, John Czajka, MD, Toni Hansen, CCRC, Patrick Marinello, Ashar Ata
Division of Orthopaedic Surgery, Albany Medical College Albany, NY

Presented at the 2010 AMC Orthopaedic Surgery Annual Resident Thesis Day

Background:
Background: Osteoarthritis
Osteoarthritisofofthe
theshoulder
shouldercan
canbebetreated
treatedbybyboth total
either arthroplasty
total arthroplastyandorhemiarthroplasty.
hemiarthroplasty. Several
Sev-
studies comparing
eral studies the two
comparing thetechniques have have
two techniques foundfound
eithereither
slightly betterbetter
slightly resultsresults
for total
for arthroplasty at short-term
total arthroplasty at short-
follow-up or no difference.
term follow-up The purpose
or no difference. of thisof
The purpose study
this was
studytowas
compare the outcomes
to compare of hemiarthroplasty
the outcomes and total
of hemiarthroplasty and
total shoulder
shoulder arthroplasty
arthroplasty in patients
in patients with osteoarthritis
with osteoarthritis and anand an intact
intact rotatorrotator
cuff. cuff.

Methods:and
Materials Thirty-four
Methods: shoulders withshoulders
Thirty-four osteoarthritis
withand an intact rotator
osteoarthritis and ancuff, who
intact had received
rotator cuff , whoa total or hemi-a
had received
arthroplasty,
total were clinically
or hemiarthroplasty wereevaluated
clinicallywith range of
evaluated motion,
with rangestrength, University
of motion, strength,of CaliforniaofatCalifornia
University Los Angelesat Los
(UCLA)(UCLA)
Angeles shouldershoulder
scale and the and
scale Western Ontario Ontario
the Western Osteoarthritis of the Shoulder
Osteoarthritis (WOOS)(WOOS)
of the Shoulder index. index.

Results: No
Results: Nosignificant
significantdifferences
differenceswere
werefound
foundbetween
betweentotal
totalshoulder
shoulderarthroplasty
arthroplastyand
andhemiarthroplasty
hemiarthroplastyregarding
regard-
ing shoulder
shoulder scores,
scores, strength,
strength, flexion,
flexion, abduction
abduction or internal
or internal rotation
rotation at anataverage
an average 39 months
39 months follow-up
follow-up (15-145
(15-145 months).
months). A difference in external rotation was found favoring total shoulder arthroplasty
A difference in external rotation was found favoring total shoulder arthroplasty (14 ; p = 0.03).
0 (140
; p = 0.03).

Conclusions:AtAtananaverage
Conclusion: average3939months
monthsfollow-up,
follow-up,thetheresults
resultsofofprimary
primarytotal
totalshoulder
shoulderarthroplasty
arthroplastyand
andhemiarthro-
hemiar-
throplasty for osteoarthritis with an intact rotator cuff are similar for range of motion, strength, and quality
plasty for osteoarthritis with an intact rotator cuff are similar for range of motion, strength, and quality of life. of life.

Introduction Materials and Methods


Charles Neer II designed the first modern shoulder hemi- Patient Selection
arthroplasty in 1951. Although it was initially designed The billing records of a large orthopaedic group (Capital
for fracture-dislocations and avascular necrosis, it was Region Orthopaedics in Albany, NY) were searched for
also used for arthritis. Problems using the prosthesis in all cases of shoulder hemiarthroplasty and total shoulder
rotator-cuff deficient shoulders and with glenoid erosions replacement since 2000. Search criteria were shoulder
prompted Neer’s next design, the total shoulder arthro- arthroplasty for reason other than fracture (CPT 23470,
plasty, in 1974. Since that time, both general shoulder 23472) and surgery performed by an orthopaedist perform-
design types have been used for glenohumeral arthritis. ing more than one arthroplasty per year. Charts were then
Significant controversy still exists, however, reviewed to identify patients for inclusion.
in patients with osteoarthritis and an intact rotator cuff.
Several studies have compared outcomes after total and Inclusion criteria:
hemiarthroplasty for osteoarthritis and have found either • Diagnosis of osteoarthritis in clinical or operative
slight favor for total arthroplasty regarding pain relief notes.
and flexion at short-term follow-up or no difference1-6. • Intact rotator cuff in operative note.
Their heterogeneity, inconsistent use of shoulder scores, • Surgery performed greater than one year prior to
occasional use of patients with rotator cuff tears, and study.
short-term follow-up make it difficult to reach a conclu-
sion on the subject. Exclusion criteria:
Further, failed hemiarthroplasties are often • Other arthritic diagnosis such as rheumatoid arthritis,
revised to total shoulders and failed total arthroplasties gouty arthritis, cuff tear arthropathy or avascular
often convert to hemiarthroplasties. Whether these revised necrosis of the humeral head.
shoulders are clinically similar to primary arthroplasties is • Diagnosis of rotator cuff tear or lack of rotator cuff
also debated. This is important, as some may claim that a notation in chart.
benefit of hemiarthroplasty is the easy conversion to total • Less than one year follow up.
arthroplasty at a later date, for example.The purpose of this • Revision of primary arthroplasty.
study, was to compare the outcomes of hemiarthroplasty Seventy seven shoulders (33 hemiarthroplasties
and total shoulder arthroplasty in patients with osteoar- and 44 total arthroplasties) performed by 6 surgeons fit the
thritis and an intact rotator cuff. criteria for inclusion in the study. Thirty-four shoulders

28
Table 1: Range of Motion for Primary Shoulder Arthroplasty

Motion Type Hemi (avg) TSA (avg) Difference (CI) p-value z-score

Flexion 1230 1320 90 (-29 to 11) 0.3641 0.3850

Abduction 1040 1150 110 (-36 to 15) 0.4114 0.5235

Int. Rotation 650 600 50 (-8 to 19) 0.4459 0.3652

Ext. Rotation 330 470 140 (-26 to -1) 0.0300 0.0676

TSA = Total Shoulder Arthroplasty, CI = Confidence Interval

in 33 patients were available for clinical evaluation, and Within the hemiarthroplasty group, the average
form the study group. age of patients was 63 years. Average follow-up was
48 months and median was 39 months (range 15- 145
Clinical Evaluation months). There were 9 men and 4 women. Three shoul-
Patients were asked to return to the office for a physi- ders had undergone a previous procedure. One received
cal exam, evaluation by the UCLA Shoulder Scale, and a labral debridement, one a debridement and excision of
completion of a questionnaire. Range of motion and loose bodies, and one had excision of loose bodies, acro-
strength were tested through flexion, abduction, internal mioplasty and open distal clavicle excision.
rotation and external rotation. The questionnaire was the Within the total arthroplasty group, the average
WOOS Index, a validated scoring system for quality of age of patients was 68 years. Average follow-up was 32
life assessment. months and median was 28 months (range 14- 79 months).
There were 15 men and 5 women. Two shoulders had
Consent previously undergone arthroscopic labral debridement.
Our study protocol was approved by our facility’s Insti-
tutional Review Board. All patients provided consent for Range of Motion
participation. There was no significant difference in range of motion
between the two groups for flexion, abduction, or inter-
Data Analysis nal rotation using t-test or ranksum analysis. There was
T-tests and ranksum analysis were used to compare the significantly better external rotation with total arthro-
two groups regarding range of motion, strength, the UCLA plasty, 470 vs. 330 (p=0.03) using the t-test. Ranksum
scale and the WOOS index. analysis found no significant difference in external rotation
(z=0.0676) (Table 1).
Results
Of the 34 shoulders studied, 13 received hemiarthroplasty Strength
and 21 received total arthroplasty. The average follow- No differences were found comparing strength of flexion,
up was 39 months and the median was 31 months (range abduction, internal rotation or external rotation for the
14-145 months). primary or revision groups using either t-test or ranksum
analysis (Table 2).

Table 2: Strength for Primary Shoulder Arthroplasty

Strength Type Hemi (avg) TSA (avg) Difference (CI) p-value z-score

0.15 (-0.23 to
Flexion 4.76 4.61 0.4347 0.4890
0.54)
0.23 (-0.60 to
Abduction 4.53 4.76 0.2423 0.3152
0.15)
0.05 (-0.35 to
Int. Rotation 4.38 4.33 0.7940 0.8530
0.45)
0.14 (-0.49 to
Ext. Rotation 4.53 4.67 0.4699 0.4614
0.23)
TSA = Total Shoulder Arthroplasty, CI = Confidence Interval

29
Table 3: Shoulder Scores for Primary Shoulder Arthroplasty
Shoulder Score Hemi (avg) TSA (avg) Difference (CI) p-value z-score
UCLA 28.1 30.0 1.9 (-5.3 to 1.5) 0.2711 0.0840
WOOS 79 88 9 (-424 to 89) 0.1937 0.0956
TSA = Total Shoulder Arthroplasty, CI = Confidence Interval

Shoulder Scores being a completely unaffected quality of life as relates to


No difference was found in either the UCLA scale or the shoulder. This index was developed specifically for
WOOS index between the primary arthroplasty groups shoulder osteoarthritis and consists of 19 questions.
using t-test and ranksum analysis (Table 3). We also included the UCLA shoulder score
which, unlike the Constant, ASES, SPADI or SST, was
Discussion designed to assess outcome after shoulder arthroplasty.
Our study showed little difference between primary total While many studies utilize other shoulder scores or sev-
shoulder arthroplasty and hemiarthroplasty for osteoarthri- eral scores for comparison, only the UCLA score assesses
tis with an intact rotator cuff. While no differences were pain, function, ROM, strength and patient satisfaction. We
found in strength or the motions of flexion, abduction or found no significant difference in UCLA score between
internal rotation, a 140 difference in external rotation in the two groups.
favor of total arthroplasty was significant. It is possible This study included only patients with an intact
that the exposure of the glenoid in total shoulders may rotator cuff noted at the time of surgery. Large rotator cuff
lead some surgeons to also release the subscapularis off tears in total shoulder arthroplasty are associated with less
of the anterior scapula, leading to greater external rotation postoperative motion, more pain, and loose components7.
postoperatively. The z-score of the ranksum analysis did This is likely due to a “rocking horse effect” of the head
not show significance for external rotation, but showed on the glenoid and, thus, stress on the glenoid component/
a trend toward significance, and the confidence interval glenoid bone interface.8 Despite this knowledge, sev-
for the t-test was large, suggesting a large variability in eral studies investigating differences between total and
data. Flexion and external rotation were also found to be hemiarthroplasty for shoulder osteoarthritis have failed
better in total shoulders at 4 years in another study, but to exclude patients with rotator cuff tears from the study
that study included patients with rotator cuff tears in the population1,2,5,9.
hemiarthroplasty group, introducing bias in favor of the In conclusion, primary total shoulder arthroplasty
total shoulder group.2 and hemiarthroplasty for osteoarthritis with an intact
As with another study comparing WOOS index rotator cuff are similar in range of motion, strength, and
scores, we found no difference between the primary ar- quality of life at an average 3.25 years follow-up. The
throplasty groups.3 While the previous study found no statistically significant difference found for external
difference at 2 years, our findings are at an average of 3.25 rotation favoring total shoulder arthroplasty may not be
years. The WOOS index measures quality of life through clinically relevant.
physical symptoms, recreation/work, lifestyle, and emo-
tions. The score is given as a number out of 100, with 100

References

1. Haines JF, et al. The results of arthroplasty in os- 3. Lo IK, et al. Quality of life outcome following
teoarthritis of the shoulder. J Bone Joint Surg Br. 2006; hemiarthroplasty or total shoulder arthroplasty in pa-
88:496-501 tients with osteoarthritis. J Bone Joint Surg Am. 2005;
87:2178-2185
2. Edwards TB, et al. A comparison of hemiarthroplasty
and total shoulder arthroplasty in the treatment of pri- 4. Radnay CS, et al. Total shoulder replacement com-
mary glenohumeral osteoarthritis. J Shoulder Elbow pared with humeral head replacement for the
Surg. 2003; 12:207-213 treatment of primary glenohumeral osteoarthritis. J
Shoulder Elbow Surg. 2007; 16:396-402

30
5. Bryant D, et al. A comparison of pain, strength, 8. Franklin JL, et al. Glenoid loosening in total shoulder
range of motion and functional outcomes after hemi- arthroplasty: association with rotator cuff arthroplasty.
arthroplasty and total shoulder arthroplasty in patients J Arthroplasty. 1988; 3: 3
with osteoarthritis of the shoulder. J Bone Joint Surg
9. Sperling JW, et al. Minimum 15-year follow-up of
Am. 2005; 87:1947-1956
Neer hemiarthroplasty and total shoulder arthroplasty in
6. Clinton J, et al. Nonprosthetic glenoid arthroplasty patients aged fifty years or younger. J Shoulder Elbow
with humeral hemiarthroplasty and total shoulder ar- Surg. 2004; 604-613
throplasty yield similar self-assessed outcomes in the
management of comparable patients with glenohumeral
arthritis. J Shoulder Elbow Surg. 2007; 16:534-538

7. Edwards TB, et al. The influence of rotator cuff


disease on the results of shoulder arthroplasty for pri-
mary osteoarthritis. J Bone Joint Surg Am. 2002; 84:
2240-2248

31
Adjacent Level Effects: A Novel In Vivo/In Vitro, Active/Passive Protocol for Assessing Redistribu-
tion of Motion of the Entire Thoracolumbar Spine Following Surgical Intervention
1
Kyle A. Elsabee, 2John D. Wason, 3James Boyle, MD, 3Ronniel Nazarian, MD, 2John T. Wen, Ph.D.,
3
Allen L. Carl, MD, 1Eric H. Ledet, Ph.D.
1
Department of Biomedical Engineering, Rensselaer Polytechnic Institute, Troy, NY
2
Center for Automation Technologies and Systems, Rensselaer Polytechnic Institute, Troy, NY
3
Division of Orthopaedic Surgery, The Albany Medical College, Albany, NY

Adjacent segment disease is recognized as a potential complication of spinal fusion. In vitro testing and finite ele-
ment analyses largely indicates that fusion instrumentation placed at one level significantly changes the stress and
motion at adjacent levels. However, advances in dynamic stabilization systems and motion preserving technolo-
gies show promise for minimizing adjacent level effects. The purpose of this study was to use a new in vivo/in
vitro active/passive biomechanical testing method to quantitatively assess the three-dimensional motion redistribu-
tion of the entire thoracolumbar spine following surgical intervention during full dynamic range of motion based
on in vivo kinematics, without the confounding factors inherent in a clinical trial.

Whole bony-ligamentous thoracolumbar spines (C7 through S1) were harvested from cadavers. C7 was attached
to the end-effector of the six degree-of-freedom robot and three-dimensional in vivo kinematic data from nor-
mal healthy volunteers was loaded into the robot controller. The three-dimensional motion of 11 vertebrae were
simultaneously measured during replication of in vivo motion. After completion of the intact motion assessment,
specimens were then subjected to surgical interventions at the L4-L5 level including laminotomy, laminectomy, dis-
cectomy, facetectomy, facet screw fixation, and then pedicle screw fixation, followed by two level pedicle fixation
at L3-L5. The range of motion testing was repeated and recorded between each intervention.

With successive interventions (laminotomy, laminectomy, discectomy, facetectomy), intersegmental motion at


the L4-5 level increased and there was a redistribution of motion at adjacent levels. Pedicle screw fixation at the
L4-5 level resulted in a reduction in motion at L4-5 and a reduction at L3-4 with concomitant increases in motion at
all other levels relative to the intact state. These preliminary data indicate that surgical interventions at the L4-5
level affect motion at all other levels of the spine (from S1 up to at least T7). There is a redistribution of motion
at adjacent levels following surgical intervention that compensates for the changes in motion at the index level.
These results suggest that an intervention at one level does not strongly predispose the immediate super- and sub-
adjacent levels to substantially altered kinematics while sparing other levels, but rather that all levels are subjected
to some redistribution.
Introduction the most common changes include; disc degeneration,
Single and multi-segment spinal fusions have been used listhesis, instability, disc herniation, facet hypertrophy,
to treat spinal instability and chronic pain. Relatively high and osteophyte formation. The ambiguity of the defini-
rates of success have been reported and fusion remains a tion of this degenerative process has made the study of
good option after failure of conservative treatment. Sur- its etiology difficult.
geons and researchers as early as five decades ago began Although many reports have correlated ad-
to describe what has become known as adjacent level jacent level disease to poor functional outcomes and
disease1. Clinical follow-up of fusion patients has led to to the need for further surgical intervention, others
the publication of numerous scientific articles demonstrat- have doubted the cause and effect relationship. Some
ing changes at levels adjacent to fused segments. These report earlier degeneration in patients with fusions2,4-7
largely radiographic changes have been linked to poor while others fail to find differences between ongo-
outcomes and to time-dependant symptoms, thus adjacent ing degenerative processes and problems caused by
segment disease is recognized as a potential complication surgery8,9-11.
of spinal fusion2,3. In vitro testing and finite element analyses
Adjacent segment disease is a term with broad largely indicates that fusion instrumentation placed
meaning. It encompasses any changes that occur in a at one level significantly changes the stress and motion
mobile segment adjacent to a spinal fusion1. Some of at adjacent levels.12,13 Other studies have shown that
32
instrumented fusion causes an increase in intradiscal vivo conditions. When in vitro testing is conducted on
pressure14-17. Some reports indicate an increase in adjacent specimens consisting of three motion segments or fewer,
level motion following fusion18,19 while others report a additional artifact is introduced because the redistribu-
decrease20. tion of stress and motion is constrained at the super and
There are many reasons for the disparity in subadjacent levels.
results. Clinical studies are fraught with the difficulty of The purpose of this study was to use a new in
discerning the difference between pathology at adjacent vivo/in vitro, active/passive biomechanical testing method
levels whose progression was inherent, versus pathology to quantitatively assess the three-dimensional motion re-
that was initiated or exacerbated by fusion at an adjacent distribution of the entire thoracolumbar spine following
level. In vitro testing and finite element models afford the surgical intervention during full dynamic range of motion
luxury of eliminating the confounding effects of natural based on in vivo kinematics.
disease progression, yet, ex vivo models are generally
based on application of arbitrary loads or motions that Materials and Methods
may have limited clinical relevance. We have previously conducted work to develop a hybrid
Advanced image analysis techniques have be- in vivo to in vitro methodology for quantifying adjacent
come available for use in quantifying motion of the spine level effects. The method is based on whole spine, three
using plain radiographs. This has allowed quantitative dimensional kinematic data collected from volunteer sub-
analysis of range of motion and center of rotation of jects performing voluntary trunk range of motion activities.
patients before and after treatment and over time fol- The data were collected using three dimensional motion
lowing treatment11. The comparison of before and after tracking sensors (Flock of Birds, Ascension Technology,
data allows quantification of spinal motion redistribution. Burlington, VT) which were mounted on the skin super-
However, this valuable technology is limited to analysis of ficial to C7, T12, and S1. The data were collected at over
static images and also is limited to analyzing the number 100 samples per second throughout range of motion to the
of levels that are captured on a plain film. maximum extent achievable by the subjects. Subject mo-
In vitro mechanical testing has also been used to tion was also recorded on high definition video during the
assess adjacent level affects. The most recent techniques course of data acquisition. Previous radiographic studies
have moved beyond the “flexibility” and “stiffness” have shown less than 2° of difference between superficial
protocols originally proposed by Panjabi21,22. The newer sensors mounted on the skin in this fashion and actual
“hybrid” protocol encompasses the concepts of the flex- vertebral movement31. Data were collected during flexion,
ibility and stiffness protocols but is based on a recently extension, right and left lateral bending, and rotation as
posed theorem: that the overall range of motion of the shown in Figure 1.
spine does not change (relative to its intact state) as a result Following in vivo data collection, each data set
of surgical intervention, even if that surgical intervention recorded from the volunteers was reduced to command
affects motion at a treated level23. Thus, the overall range set to drive a robotic simulator (Puma 560, Rensselaer
of motion of the trunk will remain the same even if a surgi- Polytechnic Institute, Troy, NY). The robotic system was
cal intervention (such as fusion in the lumbar spine) alters used for in vitro testing.
the kinematics of one level. Likewise, the overall range of
motion of the head and neck will remain the same follow- Specimen Preparation
ing a cervical spine intervention. The theoretical basis for In this pilot study, three whole bony-ligamentous tho-
this is that muscles, tendons, ligaments, and other intact racolumbar spines (C7 through S1) were harvested from
tissues are trained to achieve an inherent range of motion male cadavers within 24 hours of death. Specimens were
and by replacing one component of the system (such as harvested by transection through the C6-C7 disc space
replacing an intervertebral disc with an implant) the inher- followed by circumferential release of extraneous soft
ent range of motion does not necessarily change. Although tissue, osteotomies through each rib approximately 10 cm
this theory has not yet explicitly been proven, there is lateral to the vertebrocostal joint, and transection through
evidence to support it24,25 and it is now a widely accepted the sacrum caudal to S1 with a reciprocating saw. Care
basis for in vitro for biomechanical testing23,26. was taken not to disrupt the facet capsules, ligaments, or
Advances in dynamic stabilization systems intervertebral discs of all levels. Once excised, the bony-
and motion preserving technologies show promise for ligamentous spines were wrapped in saline soaked gauze
minimizing adjacent level effects, however this remains and stored frozen at -20° C in plastic bags until the time
controversial27-30. Data from in vitro testing and finite of use.
element models are only able to predict clinical adjacent The skeletal dimensions of the cadaver (head to
level effects to the extent that the experimental or simu- toe length) and the C7 to S1 length were measured at the
lated mechanical and kinematic environment mimics in time of harvest. Prior to in vitro testing, the dimensions of
33
Figure 1: Three-dimensional data were previously collected from volunteers during flexion, extension, lateral bend-
ing, and torsion.
the cadaver and spine were compared to those in the data- of the C7 vertebra relative to the sacrum precisely matches
base of in vivo subjects and the most appropriate in vivo that of the position and orientation of the volunteer. The
data set (with the closest spinal and skeletal dimensions robot control is maintained throughout all range of motion
to the cadaveric spine) was retrieved for testing. maneuvers (flexion/extension, lateral bending, torsion).
Position and orientation sensors (Flock of Birds,
Intact Motion Assessment Ascension Technology, Burlington, VT) were mounted
At the time of testing, each cadaveric spine was thawed to 11 vertebrae (T7 to L5) using polycarbonate mounting
to room temperature and kept moist throughout the ex- fixtures and screws (Figure 3). The robot then moved C7
periment by saline spray. The caudal end of the spine relative to S1 in an identical fashion to the active motion
was potted in a cup fixture with Low (47° C) Melting of the in vivo volunteer in left and right lateral bending.
temperature Alloy (LMA). Screws were placed in the The three-dimensional motion of the 11 vertebrae were
sacrum to facilitate rigid fixation of the sacrum in the simultaneously measured at a rate of approximately 60
LMA. Once potted in LMA, the caudal end of the spine samples per second during spine maneuvers with the spine
and fixture were fixed to a platform rigidly attached to the in its intact state as a baseline measurement. The spine was
floor. The cranial end of the spine, (C7,) was attached to moved at 50% of the speed of the volunteers to eliminate
the end-effector of the six degree-of-freedom robot using any inertial effects. The spine was moved through three
a custom clamp, as shown in Figure 2. sets of lateral bending motion and the data from the 3rd
The three-dimensional kinematic data from the set was used for comparison.
appropriate in vivo subject was loaded into the robot
controller. The data are used to control the end-effector
relative to the sacrum such that the position and orientation

Figure 3: Eleven sensors were mounted to thoracic and


Figure 2: C7 was fixed to the end-effector of the robot lumbar vertebrae (left) to track three-dimensional mo-
using a custom clamp. tion during lateral bending (right).

34
Clinical Therapeutic Interventions pattern of increasing intersegmental motion from caudal
After completion of the intact motion assessment, speci- to cranial with peaks at T11-12 and T7-8 as shown in Figure
mens were then subjected to surgical interventions at 5. The patterns in intersegmental motion are consistent
the L4-L5 level. Each spine then underwent a successive with previous reports from in vivo studies32.
laminotomy, laminectomy, discectomy, facetectomy, facet With successive interventions (laminotomy,
screw fixation, and then pedicle screw fixation, followed laminectomy, discectomy, facetectomy), intersegmental
by two level pedicle fixation at L3-L5. The range of mo- motion at the L4-5 level increased and there was a redis-
tion testing was repeated and recorded between each tribution of motion at adjacent levels. Instrumentation
intervention. The range of motion for each vertebra was reduced motion at the index level with a redistribution at
compared to the intact state. Changes in range of motion adjacent levels as shown in Figures 6 and 7. Pedicle screw
at each level were calculated and were used to calculate fixation at the L4-5 level resulted in a reduction in motion
the redistribution of motion at adjacent levels. at L4-5 and a reduction at L3-4 with concomitant increases
in motion at all other levels relative to the intact state.
Motion Redistribution Assessment
For each treatment, at each of the 11 recorded levels of Discussion
the spine, the intact state and post-intervention three di- In this pilot study, we have introduced a novel methods for
mensional kinematic data were compared quantitatively. quantitatively evaluating the effects of surgical interven-
These data were used to quantify the redistribution of mo- tion at one level of the lumbar spine on the kinematics of
tion (if any), and thus quantify the adjacent level effects the entire thoracolumbar spine. The model is novel in that
of each treatment. in vitro spine motion is based on in vivo active voluntary
motion, not arbitrary motions or moments applied to the
Results spine. As such, the fidelity with which in vivo motion is
Representation of the typical flexion/extension motion reproduced is higher than other in vitro testing protocols
for the volunteers is shown in Figure 4. All previously and intuitively the predictive value of in vivo effects from
collected data sets were successfully converted to com- in vitro testing is also high.
mand sets for the robotic motion simulator. Preliminary The intersegmental distribution of motion of
data from in vitro testing of the intact spines showed a the intact specimens in vitro is consistent with previous

Figure 4: The data previously collected from normal healthy volunteers during flexion/extension, lateral bending,
and torsion were converted to a command set for the robotic motion simulator.
35
Figure 5: Mean intersegmental motion of intact in vitro specimens increased from caudal to cranial with characteris-
tic peaks at T11-12.

Figure 6: Frontal plane motion was captured during lateral bending.

36
Figure 7: Intersegmental motion during lateral bending intact vs. facetectomy vs. pedicle screw.

in vivo studies32. This validates the model with respect to voluntary control of the paraspinal muscles. The motion
reproduction of in vivo motion in vitro. This indicates that of the spine in vitro is representative of active physiologic
although in vitro motion of the entire thoracolumbar spine range of motion. The effects of the rib cage in stabilizing
is only controlled by manipulating C7 relative to S1, the the spinal column has also been taken into account at least
passive intersegmental motion at all levels of the spine dur- in part as rib cage was left intact and the vertebrocostal
ing in vitro testing is similar to in vivo active motion. joints left undisrupted.
These preliminary data indicate that surgical While our technique focuses on reproduction of
interventions at the L4-5 level affect motion at all other the three-dimensional kinematics of the thoracolumbar
levels of the spine (from S1 up to at least T7). There is a re- spine, the protocol does not necessitate application of an
distribution of motion at adjacent levels following surgical axial preload or follower load to the in vitro specimens33.
intervention that compensates for the changes in motion The reported advantage of applying a follower load to
at the index level. Relative to an intact state, fusion at the specimens in vitro is to stabilize the spine and foster higher
L4-5 level reduced motion at L4-5 and L3-4 and increased fidelity reproduction of spine motion when the specimen is
motion at all other levels. The extent of redistribution of tested in unconstrained motion34. Using the in vivo/in vitro
motion was small, less than 1° of motion in most cases, active/passive protocol, it is not clear that application of a
but was consistent at all levels. Importantly, these results follower load would add to the fidelity of the kinematics
suggest that an intervention at one level does not strongly or mechanics of the specimens in vitro.
predispose the immediate super- and sub-adjacent levels The novel method described facilitates com-
to substantially altered kinematics while sparing other prehensive evaluation of the entire thoracolumbar spine
levels, but rather that all levels are subjected to some for adjacent level effects following surgical intervention.
redistribution. Preliminary data indicate that motion is redistributed
As with all new models, there are associated throughout the spine and not just at the levels immediately
strengths and limitations using this technique. This model adjacent to the intervention. Future work will include
allows each individual vertebral segment to be studied evaluations of motion sparing and dynamic stabilization
both before and after surgical interventions to identify any therapies and the effects of an axial preload on spine
changes in motion at a given level. The motions during kinematics.
in vitro testing are based on active in vivo motion under

37
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bosacral fusion: review of the literature. Spine. 2004; fusion. Spine. 1998; 23(16):1785-92.
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11. Axelsson P, Johnsson R, Stomqvist B. Adjacent
2. Lee CK. Accelerated degeneration of the segment segment hypermobility after lumbar spine fusion. No
adjacent to a lumbar fusion. Spine. 1988; 375-77. association with progressive degeneration of the seg-
ment 5 years after surgery. Acta Orthopaedica. 2007;
3. Disch AC, Schmoelz W, Matziolis G, Schneider SV,
78(6): 834–839.
Knop C, Putzier M. Higher risk of adjacent segment
degeneration after floating fusions: long-term outcome 12. Lee CK, Langrana NA. Lumbosacral spinal fusion
after low lumbar spine fusions. J Spinal Disord Tech. – a biomechanical study. Spine. 1984; 9(6):574-81.
2008;21:79–85.
13. Dekutoski MB, Schendel MJ, Ogilvie JW, Olsewski
4. Lehmann TR, Spratt KF, Tozzi JE, Weinstein JN, JM, Wallace LJ, Lewis JL. Comparison of in vivo and
Reinarz SJ, El-Khoury GY, Colby H. Long-term in vitro adjacent segment motion after lumbar fusion.
follow-up of lower lumbar fusion patients. Spine. 1987; Spine. 1994; 19(15):1746-51.
12(2):97-104.
14. Kim YE, Goel VK, Weinstein JN, Lim TH. Effect
5. Etebar S, Cahill DW. Risk factors for adjacent- of disc degeneration at one level on the adjacent level
segment failure folllowing lumbar fixation with rigid in axial mode. Spine. 1991; 16(3):331-5.
instrumentation for degenerative instability. J Neuro-
15. Weinhoffer SL, Guyer RD, Herbert M, Griffith
surg. 1999; 90(2 Suppl):163-9.
SL. Intradiscal pressure measurements above an in-
6. Aota Y, Kumano K, Hirabayashi S. Postfusion insta- strumented fusion. A cadaveric study. Spine. 1995;
bility at the adjacent segments after rigid pedical screw 20(5):526-31.
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16. Cunningham BW, Kotani Y, McNulty PS, Cappuc-
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cino A, McAfee PC. The effect of spinal destabilization
7. Yang JY, Lee JK, Song HS. The impact of adjacent and instrumentation on lumbar intradiscal pressure.
segment degeneration on the clinical outcome after An in vitro biomechanical analysis. Spine. 1997;
lumbar spinal fusion. Spine. 2008; 33(5):503–7. 22(22):2655-63.

8. Van Horn JR, Bohnen LM. Development of dis- 17. Eck JC, Humphreys SC, Lim TH, Jeong ST, Kim
copathy in lumbar discs adjacent to a lumbar anterior JG, Hodge SD. An HS. biomechanical study on the
interbody spondylodesis. A retrospective matched-pair effect of cervical spine fusion on adjacent-level intra-
study with a postoperative follow-up of 16 years. Acta discal pressure and segmental motion. Spine. 2002;
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39
The Role of Extensor Muscle Fatigue in the Onset of Intervertebral Disc Degeneration:
An In Vivo Model
Mary Beth M. Grabowsky, MS1, Nicholas A. Pallotta, MS1, Matthew W. Connelly, MS1, Brett Van Etten2,
Rebecca A. MacDonald, MS1, Maxwell Alley4, Joseph C. Glennon, VMD3, Andrew H. Dubin, MD4,
John W. German, MD4, Richard L. Uhl, MD4, Eric H. Ledet, Ph.D.1
1
Rensselaer Polytechnic Institute, Troy, NY
2
University of Vermont, Burlington, VT
3
Veterinary Medical Specialties, Pattersonville, NY
4
Albany Medical College, Albany, NY

Epidemiologic evidence indicates a correlation between occupation and the development of low back pain (LBP) and
degenerative disc disease (DDD). Specific occupational activities associated with LBP include poor posture, whole
body vibration, and repetitive lifting. These activities have a common link: they result in fatigue of the primary spi-
nal extensor musculature supporting the spine. This fatigue has been shown to cause recruitment of both secondary
agonist, as well as antagonist muscles to maintain support of the spine. However, this fatigue and accompanying
recruitment may lead to increased intervertebral loading – a stimulus for disc degeneration. This association is a vital
connection between everyday physical activities and LBP. However, this link between muscle fatigue and increased
load across the disc space has never been quantified in vivo. The purpose of this study is two-fold: 1) to develop
and test a wireless force-sensing interbody implant, and 2) to create an in vivo large animal model to study primary
extensor muscle fatigue. Combined, these tools allow in vivo spinal forces to be measured prior to and following
muscle fatigue to determine alterations in loading due to fatigue.

Introduction: tigue over time 9,10,11,12. Similarly, whole-body vibration


It is estimated that up to 80% of the general population will causes instability of the spine as well as fatigue in the
experience at least one significant bout of low back pain spinal musculature, especially at its resonant frequency
(LBP) in their lifetime1,2. LBP had the highest prevalence of 5 Hz.13,14,15,16. Additionally, frequent and heavy lifting,
of any reported medical condition in 2005, with up to 40% in itself has been shown to cause fatigue in the primary
of the United States adult population stating that they had spinal extensors17,18.
experienced low back pain in the previous 3 months. This Primary extensor muscle fatigue initiates recruit-
is more than two times the incidence of other common ment of secondary agonistic muscles to help support the
maladies including pain in other joints such as the hip, spine19,20,21,22,23. For example, when the erector spinae
knee, or shoulder (8%, 15%, and 12% respectively)3. The complex is fatigued, it will recruit the multifidus muscles.
leading known cause of low back pain is degenerative disc However, unlike the primary extensor muscles, these
disease (DDD) 3,4,5. secondary muscles are normally much shorter and less
Over the past decade, mechanical, genetic, and optimized for supporting the spine. In addition to these
psychosocial factors have been linked to the onset of secondary muscles, the body will also recruit antagonistic
disc degeneration, and it has been further shown that muscles to prevent spine instability. Although normally
these risk factors are cumulative6,7,8. The majority of the categorized as a primary spinal flexor, the activity of the
well-established risk factors for LBP are mechanical in rectus abdominus muscles have been shown to increase
nature, and are often related to activities of daily living following erector spinae fatigue24. Appropriately, the cor-
and everyday work activities such as poor postural control, relation between patients with low back pain and an in-
experiencing whole-body vibrations, and frequent lifting. creased recruitment of agonistic and antagonistic muscles
Despite these correlations, the underlying mechanism by has also been demonstrated25,26,27.
which DDD and LBP develop remains unclear. Primary extensor muscle fatigue causes altered
One common link between these activities is spinal recruitment patterns. The link between altered
that they can cause prolonged submaximal muscle activ- muscle activity and spinal degeneration may be the result
ity in the primary spinal extensor muscles. Intuitively, of a net increase in force across the disc space28,29. How-
muscle fatigue may play a role in the development of ever, this has not yet been proven experimentally.
DDD and LBP. Poor posture forces the extensor muscles Several types of these mathematical models
to work harder to support the spine, and thus causes fa- have been developed and the process of estimating spinal
40
loads has become increasingly complex through the use of
multiple technologies, such as electromyography (EMG)
and finite element analysis (FEA)30,31,32. However, these
techniques have not been verified by direct in vivo data.
Limited in vivo studies using instrumented inter-
body implants and posterior implants have been conducted
to monitor loads in the spine33,34. While these instrumented
implants have collected data which provide insight into
the changing forces as a function of activities, they have
been limited because they are designed around fusion
devices. These implants inhibit the natural motion at the
level of interest and therefore cause an artifact in the data.
As an alternative, a multi-axial articulating force-sensing
implant overcomes this limitation. Furthermore, current
research with these force-sensing implants has been lim-
ited to brief sessions recording load data during normal
activities, such as sitting and standing, while changes in
disc space forces as a function of primary muscle fatigue
have never before been measured. The purpose of this
study was: 1) to develop and test a wireless force-sensing
interbody implant, and 2) to create an in vivo large animal
model to study primary extensor muscle fatigue. Using
the combination of these tools, changes in multi-axial
forces in the disc space can be measured in vivo prior to
and following muscle fatigue, thereby providing data on
an incompletely understood step in the disc degeneration
process.

Materials and Methods


Implant Design
We developed a novel wireless force-sensing implant simi- Figure 1 – (Above) An exploded CAD view of the
lar to many current total disc replacements. The implant multi-axial implant depicts the superior concave compo-
has distinct superior and inferior articulating components nent which articulates on the inferior convex assembly.
to allow for vertebral motion and the collection of multi- (Below) A prototype of the implant shown in lateral
axial force data through wireless sensors, as shown in bending.
Figure 1. During articulation of adjacent vertebrae in
flexion, extension, lateral bending, or a combination of force, the anterior/posterior shear force, and the left/right
these movements, the superior concave component of lateral shear force. An analytical model was developed
the implant articulates on the three force transfer struts wherein once the sensors are experimentally calibrated
arranged convexly in the inferior component assembly. such that a voltage-force relationship is determined, the
Embedded below the force transfer struts are three capaci- three forces measured by the sensors can be used, along
tive wireless sensors. The orientation and geometry of the with their constant orientation parameters, to determine
struts ensures that they remain normal to the contacting the three components of the load being applied as is shown
surface of the superior component during articulation. A in Figure 2.
single strut is centered anteriorly, while the remaining two When taking readings from the implant, each
are located posterolaterally, equidistant from the centerline sensor’s force is used in combination with the following
and each 110 degrees from the anterior strut in the axial equations to calculate the axial compressive and shear
plane. These struts allow the entire load seen in the anterior forces.
(Equation 1)
and middle columns of the spine to be transferred to the
three sensors in a unique distribution dependent upon the
positioning of the adjacent vertebrae. (Equation 2)
The distribution of forces measured by the three
sensors facilitates calculation of the multi-axial forces be- (Equation 3)
ing applied to the implant, including the axial compressive
41
Figure 2 – The three wireless sensors are arranged in an array within the inferior component such that their force
transfers each always apply a fraction of the total force along their respective vectors. These constant parameters aid
the calculation of the compressive and lateral shear forces.

Implant Experimental Model in this study. To develop the fatigue model, the goats
To experimentally validate our implant design, a func- were anesthetized and needle electrical stimulation was
tional, scaled model of the implant was created into which employed bilaterally to repeatedly activate the splenius.
three subminiature button load cells were integrated. The The goats were placed in a sling such that its body was
model was assessed by applying both axial and eccentric supported in a prone position with legs suspended, as
loads up to 445 N using a custom-built seven degree of shown in Figure 4. Two cables were attached to either
freedom spine testing machine, as shown in Figure 3 be- side of a halter and were extended downward to attach in
low. The forces measured by the button load cells were series with a miniature load cell. Needle electrodes were
used to back-calculate the applied load via the analytical placed bilaterally in the splenius to stimulate it while
model (Equations 1-3). The calculated values were then minimizing co-contraction of adjacent muscle groups.
compared to the actual applied load. During stimulation of the splenius, the load cell-halter
system was used to monitor and record the head extensile
Implant Computational Model and Finite Element force elicited by the stimulation. These data were used to
Analysis determine the extent of fatigue.
Validation of the implant design was also achieved using
finite element analyses (FEA). A computer generated Results
model of the implant was created using SolidWorks (Das- Implant Experimental Model
sault Systèmes SolidWorks Corporation, Concord, MA) Results of the experimental model of our articulating
and analyzed using CosmosWorks (Dassault Systèmes multi-axial implant demonstrated excellent agreement
SolidWorks Corporation, Concord, MA). This analysis
included loading the implant both axially, as well as in
flexion, lateral bending, and combinations thereof. The
loads transferred to the sensors were again used to cal-
culate the applied loads, and these computed values were
compared to the actual applied loads.

Fatigue Animal Model


The goat cervical spine is a well established analog to
the human lumbar spine because it has a similar structure
and loading pattern and is oriented vertically35,36. The
splenius is the most superficial of the intrinsic muscles in
the goat cervical spine and is primarily responsible for
extension of the neck. It is an analog to the human erector
spinae complex which is primarily responsible for trunk
extension in the lumbar spine. Figure 3 – An experimental model of the wireless
Following IACUC approval, four skeletally multi-axial implant is tested in a custom seven degree of
mature male Alpine-Nubian cross-bred goats were used freedom spine testing machine.

42
Figure 4 – A diagram of the goat during fatigue testing illustrates the head halter which is in series with the load cell
(a) and the needle electrodes, a close-up of which is shown in (b).

between the calculated and actual applied loads. The This combination provided the low frequency stimulation
implant was first loaded in neutral compression with a desired to mimic low frequency fatigue in humans, while
maximum load of 445 N. With six trials completed in this also providing a duration and amplitude with enough force
orientation, the mean axial, A/P shear, and lateral shear to cause a visible movement of the head with each stimula-
forces calculated using the button load cell results and the tion, but not cause co-contraction of nearby muscles. The
analytical model had errors less than ±22 N (or 5% error), elapsed time between the onset of stimulation (baseline
when compared to their respective applied loads. When reading) and muscle exhaustion was approximately 2
subjected to eccentric loading, the mean error in measured hours. The initial baseline reading illustrated distinct peaks
loads was also less than ±22 N. with consistent magnitudes averaging approximately 37
N. The first sign of fatigue detected was variability in the
Implant Computation Model and Finite Element force magnitude of each peak, and an increasing standard
Analysis (FEA) deviation within each 10 second segment was observed
Table 1 shows the results of the finite element analysis. as the test progressed. The decrease in average amplitude
The implant underwent loading in the neutral position over the 2 hours was linear with a correlation coefficient
via an applied axial load and in the flexed and laterally of 0.81, as shown in Figure 5. The last data set before a
bent positions via off-axis loads. All of the loads were ten minute pause at the end of the study exhibited only
calculated within 0.3 % error of the applied loads and the four of the ten expected response peaks with an overall
angles within 0.2 degrees. average magnitude for the set just over 5 N. After the ten
minute pause at the end of the study, the first ten second
Fatigue Animal Model data set demonstrated that the mean peak amplitude was
The optimal electrical stimulation parameters were de- still indistinguishable from noise and that the muscles had
termined iteratively and consisted of a frequency of 1 not recovered from the fatigue.
Hz with a 200 μs duration and an amplitude of 300 volts.

Table 1 - Calculated forces and angles which resulted from finite element analysis and the analytical model were
determined within 0.3% error.
Degrees
Applied Sensor 1 Sensor 2 Sensor 3 Calculated Calculated Percent
Position from
Load (N) (N) (N) (N) Angle (°) Force (N) Error (%)
Vertical
150 Flexion 2 33.59 59.89 59.81 1.82 150.30 0.200
150 Flexion 4 16.06 68.56 68.46 3.98 150.37 0.246
150 Lateral Bending 2 51.06 66.35 35.96 2.00 150.30 0.200
150 Lateral Bending 4 50.98 81.38 20.74 3.99 150.39 0.260
267 Neutral 0 90.98 91.12 90.82 5.80x10-03 267.60 0.200
43
Figure 5 – A plot showing the relationship between the decrease in force response to stimulation and the elapsed
time of the stimulation reveals a linear relationship.
Discussion the concentric layers of the anulus fibrosis provide excel-
We have designed a wireless, articulating, multi-axial lent support with respect to axial forces, the orientation of
load cell implant. Both scaled functional models and the collagen fibers within the anulus fibrosis provide no
computational models have been tested for this implant, ability to resist shear forces.37 Furthermore, there is an
and the results of this study demonstrate that our implant increased risk of disc injury when compressive forces are
is sufficiently sensitive to measure axial and shear forces. combined with shear forces in activities such as flexion
Initial muscle fatigue testing showed that the use of elec- and lateral bending.38 Therefore, an increase in A/P and
trical stimulation was effective in isolating the primary lateral shear forces due to fatigue could be significant in
extensor muscles of the caprine cervical spine and creat- the development of degenerative disc disease.
ing low frequency fatigue. In addition, we showed that There are currently no experimental data which
using electrical stimulation at the specified parameters to relate fatigue in the primary spinal extensor musculature
stimulate the caprine cervical primary extensors can result to the magnitude of force across the intervertebral disc.
in a 100% decrease in force over a 2 hour time period. If muscle fatigue does in fact increase forces across the
In this study, the novelty of the implant is two- disc, it is a potential initiator for degenerative disc disease,
fold: the implant-sensor design itself and the unique data as increased loading is a known precursor to low back
it will provide. The multi-axial force sensing implant pain. We predict that increased muscle recruitment is the
allows for the measurement of loads directly imposed primary mechanism through which fatigue in the primary
on the vertebral bodies and discs in real-time throughout spinal extensors causes an increase in interbody forces.
a wide range of motion. In this way, the data will more There is an increased recruitment of secondary agonistic
closely reflect actual in vivo loading relative to previous muscles upon fatigue 39,40,41,42,43. However, the secondary
estimates. In addition, much of the current data available agonists in the back support one or at most a few levels
on spinal loading focuses on axial compressive forces. within the spine. Thus, the insertion and origins of these
Although the compressive force is the major component muscles are not as optimized as the primary extensors
of spinal loading, A/P and lateral shear forces are also for supporting large structures. Their recruitment as an
present in the disc space and may play a significant role adjunct to support the spine once the primary extensors
in the development of degenerative disc disease. While fatigue may be causing more harm than good. In addition,
44
although counterintuitive, there are several examples in extensors and the onset of low back pain. The overlying
the body other than the spine where fatigue in a primary process through which degenerative disc disease develops
agonistic muscle results in recruitment of antagonistic is multi-faceted and not well understood. Therefore, a
muscles for support. This antagonistic recruitment may better understanding of this link can help to prevent the
prevent injury in the short term by stabilizing the joint, onset of disc degeneration, treat patients, and elucidate
but like the secondary agonists, the antagonists provide the mechanism through which everyday activities cause
suboptimal support which may further increase the joint low back pain.
loading.
Epidemiologic data indicate correlations be-
tween activities which cause fatigue in the primary spinal

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Spine. 2003;28:1810–20. tomatic participants during lifting exertions. Clinical
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18. Kim SH, Chung MK. Effects of posture, weight and
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repetitive lifting tasks. Ergonomics. 1995;38(5):853- duna AR. Trunk muscle recruitment patterns in specific
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33. Rohlmann A, Bergmann G, Graichen F, Mayer HM.
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Spinal Disorders. 1997;10(2):145-156.

47
In Vivo Effects of Cyclic Compression on the Intervertebral Disc and Endplates
of the Lumbar Spine: A Pilot Study With a Novel Animal Model
Glenn P. Sanders, Ph.D1, Sarah E. Linley1, Gwendolyn A. Sowa, MD, Ph.D2, Joseph C. Glennon,VMD3,
Darryl J. DiRisio, MD4, James P. Lawrence, MD4, Jacqueline Vanderzanden, MD4, Elizabeth Leimer 1,
Jeffrey C. Lotz, Ph.D5, Eric H. Ledet, Ph.D1

Rensselaer Polytechnic Institute, Troy, NY


1

2
University of Pittsburgh, Pittsburgh, PA
3
Veterinary Medical Specialties, Pattersonville, NY
4
Albany Medical College, Albany, NY
5
University of California San Francisco, San Francisco, CA

Background: Epidemiologic data indicate a correlation between repeated mechanical loading of the lumbar
spine and painful degenerative intervertebral disc disease. Clinically, sclerotic changes of the vertebral endplates
and subchondral bone are often observed concomitant to intervertebral disc degeneration, however the temporal
relationship between endplate sclerosis and disc degeneration is not well characterized. The lumbar spine of the
New Zealand white rabbit is a promising model to study the response of the lumbar spine to dynamic mechanical
loading. Unlike the mouse and rat tail models however, no cyclic loading model exists for the rabbit lumbar spine.

Purpose: The purpose of this study was to characterize the correlation between cyclic axial loading and the initia-
tion and propagation of (a) intervertebral disc degeneration and (b) endplate sclerosis in our model.

Methods: Following surgical placement of transfixing pins and dorsally extending percutaneous posts, the lumbar
spines of 11 New Zealand white rabbits were loaded cyclically via an external apparatus for two hours per day,
five days per week. Loads were applied at 5 x BW at either 0.5 Hz for 10 weeks (n=4), 0.5 Hz for 26 weeks (n=2),
5 Hz for 8 weeks (n=2), or 5 Hz for 30 weeks (n=2). One animal (n=1) was designated as a surgical control animal
and underwent the identical surgical procedure as the other animals but received no daily loading. Serial plain
radiographs were used to monitor changes in the spine. Spines were harvested and diffusion and disc health were
analyzed using post-contrast enhanced MRI imaging. Endplate thickness and bone density were quantified via
microCT analysis. Disc and endplate changes were characterized by gene expression analysis and histopathology.

Results: Results indicate that the disc, endplates, and subchondral bone degenerate in response to cyclic mechani-
cal loading. Endplate cartilage thins and calcifies, resulting in thickened sclerotic subchondral bone. Diffusion to
the disc is reduced proportionally to the extent of sclerosis. The disc becomes fibrotic and disorganized, the extent
of which is proportional to load exposure. The observed trends in gene expression analysis suggest that the slower
accumulation of load cycles in the low frequency group may have a beneficial effect on matrix homeostasis and
inflammation in our model, whereas the rapid accumulation of cycles in our high frequency group may stimulate
matrix synthesis accompanied by pro-inflammatory and catabolic activity.

Conclusions: We have developed an apparatus, a technique, and an animal model to study the long-term effects of
mechanical loading on the intervertebral disc, endplates, and subchondral bone in the lumbar spine in vivo. Physi-
ologic mechanical loading alone will initiate degenerative changes in the intervertebral disc and sclerotic changes
in the endplates accompanied by a reduction in passive diffusion from the subchondral bone to the disc. Rapid
accumulation of cycles stimulated matrix synthesis accompanied by pro-inflammatory and catabolic activity,
whereas the slower accumulation of cycles may have a beneficial effect on matrix homeostasis and inflammation
in our model. Results indicate that mechanisms affecting subchondral bone density also affect disc diffusion and
homeostasis.

Introduction chanical loading of the lumbar spine and painful degenera-


Low back pain is a leading cause of disability, lost wages, tive intervertebral disc disease.4-8
and physician office visits.1-3 The causes of low back pain Clinically, sclerotic changes of the vertebral
are complex and not fully understood, but epidemiologic endplates and subchondral bone are often observed con-
data indicate a strong correlation between repeated me- comitant to intervertebral disc degeneration. However, the
48
temporal relationship between endplate sclerosis and disc larger physical size of the rabbit lumbar spine relative to
degeneration is not well characterized. The endplates and the rat and mouse suggest its utility as a model to study
subchondral bone play a critical role in intervertebral disc the response of dynamic mechanical loading. Unlike the
homeostasis via regulation of small molecule diffusion to mouse and rat tail models however, no cyclic loading
and from the avascular disc.9-12 There is evidence to sug- model exists for the rabbit lumbar spine.
gest that bony endplate sclerosis occurs secondary to disc To comprehensively characterize the complex
degeneration as a result of altered loading distributions interplay between the intervertebral disc, vertebral end-
relative to a healthy disc.13 Yet, there is also evidence plates, and subchondral bone in response to repeated
indicating that the temporal sequence is reversed, and mechanical loading, we have developed a novel in vivo
that sclerotic endplates initiate disc degeneration via a animal model. The purpose of this study was to character-
reduction in diffusion to and from the disc.14 ize the correlation between cyclic axial loading and the
In diarthrodial joints, subchondral bone remod- initiation and propagation of intervertebral disc degenera-
els in response to mechanical loading.15 Increasing bone tion and endplate degeneration in our model.
density and reduction in porosity correlate to exposure to
cyclic loading. These changes have been indicated as a Materials and Methods
possible initiator of osteoarthritis via a reduction in diffu- We have developed an external apparatus for applying
sion to the articular cartilage.16 Changes in vertebral sub- chronic, cyclic, compressive, axial-only loads to the
chondral bone are common,17 but the correlation to cyclic lumbar spine of a live animal. The loading apparatus
mechanical spinal loading has received little attention. (“The Degenerator”) is a novel portable external ap-
The response of the intervertebral disc (both anu- paratus capable of applying axial compressive forces at
lus fibrosis and nucleus pulposus) to repeated mechanical controlled magnitudes and frequencies. The Degenerator
loading has been studied previously, primarily through uti- interfaces with the spine to apply loads by engaging four
lization of the rat caudal (tail) vertebrae model.18-21 Using percutaneous posts that extend dorsally from the vertebral
this in vivo model, the metabolic response of the disc to bodies. During loading, The Degenerator is attached to the
loads of varying magnitude, frequency, and duration have posts, and following loading, it is disengaged. The four
been described. The rat tail model is unique in that it allows percutaneous posts are attached to two adjacent lumbar
for study of the gradual onset of chronic disc degeneration vertebrae via two transfixing pins that extend bilaterally
resulting from mechanical loading, whereas other com- from the vertebral bodies (one per vertebra). During load-
mon animal models utilize iatrogenic anular disruption ing, the animals are placed into the apparatus awake, and
or chemical alteration to initiate disc degeneration.22-24 unrestrained.
While the rat tail model has yielded valuable data for In this study, we utilized 11 skeletally mature
characterizing the response of the disc to loading, the (>4.5 kg) New Zealand White (NZW) rabbits to test our
effect of loading on the endplates and subchondral bone apparatus and to characterize the effects of cyclic loading
have not been studied in this model. Rat vertebral physes on the intervertebral disc and endplates.
remain open throughout adulthood25,26 and caudal motion
segments lack posterior elements and zygapophyseal Apparatus
joints, potential confounding factors for elucidating the The Degenerator utilizes a single linear actuator (Mirai
critical role of the endplates and subchondral bone in the Inter-Technologies, Rochester, NY) which interfaces with
degenerative process. a personal computer and moves under closed-loop control.
The lumbar spine of the New Zealand white Through a series of bearings, the motion of the actuator is
(NZW) rabbit is a promising alternative model. The transferred to a clamping mechanism which secures the
vertebral physes close at skeletal maturity and there re- Degenerator to the percutaneous posts (and thus the spine).
main only sparse cells of the notochord phenotype in the By aligning the actuator with the long axis of the spine, it
disc.27-29 With respect to dynamic loading, the resonant applies an axial-only load (no bending or torsion) to the
frequency of the rabbit spine is 4.5 Hz, similar to that of spine even if the percutaneous posts are not perpendicular
the human spine.30,31 Pressures in the human intervertebral to the spine or parallel to each other. The Degenerator al-
disc have been measured at 2.6 MPa during activities of lows for control of load frequency, duration, magnitude,
daily living at forces that correspond to approximately and displacement. The apparatus is mounted to a cart and
6 times body-weight.32,33 Based on the morphology and extends below to the top of a rabbit restrainer system (Plas
cross-sectional area of the skeletally mature NZW rabbit Labs, Lansing, MI) mounted directly underneath. The ani-
lumbar intervertebral disc, an axial load of approximately mal is placed in a restrainer and the clamping mechanism
6 times body weight corresponds to a stress of approxi- is attached to the percutaneous posts.
mately 2.6 MPa in the disc.34,35 These properties and the

49
Figure 1: Transfixing pins are used to attach stainless steel posts to adjacent vertebrae (left). The posts extend percu-
taneously to attach to the external loading apparatus (right).

Apparatus-Spine Interface allow for bony ingrowth into the pins during which their
For interfacing the loading system with the lumbar spine, acclimation to the apparatuses was continued.
we chose to modify the technique described by Kroeber et
al42 where transfixing pins are placed transversely through Loading Regimen
adjacent vertebral bodies and attached to dorsally extend- One animal (n=1) was designated as a surgical control
ing percutaneous posts. After IACUC approval, using animal and underwent the identical surgical procedure
general anesthesia standard aseptic techniques, sharp and as the other animals but received no daily loading. At ap-
blunt dissection were used to expose the lateral aspect proximately 4 weeks post-operatively, the other animals
of the lumbar spine via a single 10 cm lateral incision to began their daily loading regimen for 2 hours, five days
facilitate placement of the transfixing pins. The anatomic per week. Animals were loaded cyclically from no load to
landmark for caudal pin insertion is 3 mm from the caudal 220 N at either 0.5 Hz for 10 weeks (n=4), 0.5 Hz for 26
endplate of the caudal vertebral body at the interface of weeks (n=2), 5 Hz for 8 weeks (n=2), or 5 Hz for 30 weeks
the transverse process and vertebral body. The landmark (n=2). A 220 N load is approximately 5 x BW for the 4.5 kg
on the cranial vertebra is approximately 3 mm from the animals. This is within the range of estimated physiologic
cranial endplate and 1 mm ventral to the ridge where the loading in the lumbar spine of humans during activities
transverse process transitions into the vertebral body, as of daily living36-38 and similar to force levels used in other
shown in Figure 1. models.39-43 Based on our previous work measuring the
A 1 mm k-wire was drilled through the vertebral morphometric properties of the rabbit intervertebral disc,
body at each location. The k-wires were then removed the mean cross-sectional area of the disc is approximately
and a 2 mm transfixing pin with 2.5 mm central threaded 95 mm2 resulting in a disc space stress of approximately
region (IMEX Veterinary, Inc., Longview, TX) was placed 2.3 MPa.34,35 Five times body weight applied to a typical
into the pre-drilled hole. The threaded region of each pin human lumbar intervertebral disc of cross-sectional area
was coated with nanophase hydroxyapatite (Spire, Corp., 1,800 mm2 results in a stress of approximately 2 MPa.44
Bedford, MA) to facilitate rapid osseointegration. This is consistent with intradiscal pressure measure-
Four stab incisions were then made dorsal to the ments taken from human discs during lifting (2.3 MPa)
spine to facilitate placement of each post. Incisions were and sitting while holding a weight (2.6 MPa).33,45 Based
made just cranial to the L5-6 facet joints and just caudal to on mean stiffness of the NZW lumbar motion segment,
the L3-4 facet joints. The 6 mm stainless steel posts were application of 220 N results in compression of the disc
placed blindly through the two left incisions and guided of approximately 25%. By comparison, at 5.7 X BW,
onto the left lateral aspect of the caudal and cranial trans- the human disc space narrows by approximately 25%.46
fixing pins. The right side of the transfixing pins were then Loading frequencies were chosen to mimic exposure in
trimmed using pin cutters through the lateral incision and occupations which correlate to disc degeneration such as
the right posts were placed percutaneously onto the pins truck drivers, operators of heavy machinery (5 Hz)47-49 and
through the two right stab incisions. The lateral incision manual laborers (0.5 Hz).
was then closed in layers. Sutures were used as necessary
to close the dorsal incisions around the posts. The posts Serial Plain Radiographs
were cleaned daily with betadine and antibiotic ointment Disc space narrowing, osteophyte formation, and endplate
for at least two weeks following surgery. Animals were sclerosis are clinical indicators of disc degeneration. Dur-
allowed a four week quiescent period following surgery to ing the time course of loading, plain x-rays were used
50
to measure these parameters. Lateral plain radiographs Micro CT Analysis
were taken every two weeks and digitized for analysis. Osteophytes and subchondral sclerosis are features com-
Standardized exposure times and intensities (64 kVp 2 mon to disc degeneration. Subchondral bone volume and
MA) were used. Disc Height Index (DHI)50 was measured bone mineral content were quantified to assess ectopic
at each time point and changes in loaded levels were mineralization and subchondral sclerosis. A μCT analy-
compared to unloaded adjacent levels. The presence or sis (SCANCO, vivaCT 40, Bassersdorf, Switzerland)
absence of osteophytes and changes in lucency of the was performed on loaded and adjacent unloaded levels.
endplates were graded by a single blinded investigator. Following reconstruction of 19 μm sagittal sections, a
Time-point radiographs were compared to baseline films volume-of-interest (VOI) was established which included
to assess changes. a 2 mm deep region of subchondral bone at the central 1/3
of the endplate as shown in Figure 2. VOIs were created
Administration of Contrast Agent/Euthanasia for both the cranial and caudal endplates. Bone density of
Forty-five minutes prior to euthanizing each animal the VOI was quantified at the loaded level and compared
at its designated time point, gadodiamide (Omniscan, to the adjacent unloaded levels. Mid-sagittal slices were
Amersham Health, Princeton, NJ) was administered (0.3 also used to measure endplate thickness and intervertebral
ml/kg BW, IV) to assess diffusion into the intervertebral disc height. Values from loaded levels were compared to
disc. Forty-five minutes after administration of the ga- non-loaded adjacent levels and aged matched controls.
dodiamide, animals were euthanized (Pentobarbital 100
mg/kg BW IV). The entire lumbar spine was harvested Gene Expression Analysis
en bloc, and the pins and posts carefully removed. The Immediately following post-mortem imaging, specimens
spine was sectioned into individual motion segments were either designated for gene expression analysis or
and temporarily stored in Fomblin (Sovay Solexis, West histopathology. Experimental and adjacent unloaded
Deptford, NJ) to prevent dehydration and facilitate high motion segments designated for gene expression analy-
quality MRI images. The super-adjacent, loaded level, and sis were transected through the intervertebral disc using
sub-adjacent motion segments were harvested as a basis standard aseptic technique. Samples of nucleus pulposus
for intra-subject normalization. (NP) and anulus fibrosis (AF) were harvested via sharp
dissection then snap frozen and stored at -80° C. At the
Post Contrast Enhanced T1 and T2 Mapping time of analysis, mRNA was isolated separately from AF
Diminished diffusion through the vertebral endplates
is associated with degenerative disc disease.51-53 In this
study, measurement of gadodiamide in the disc via post
contrast enhanced MRI was the primary means by which
diffusion was quantified. A series of T1 and T2-weighted
images were taken of the lumbar spine using a 7T MRI
scanner (Bruker Biospin, Billerica, MA) equipped with a
9 cm actively shielded gradient set capable of generating
magnetic field strengths of 300 mT/m and a 62 mm cir-
cularly polarized quadrature volume coil. Sagittal images
for T1 relaxation mapping were acquired using a RARE
sequence. MSME sequence scans were used for obtaining
T2 relaxation values. Regions-of-interest (ROIs) were
created in the nucleus pulposus, anterior and posterior
anulus, superior and inferior vertebral bodies, and supe-
rior and inferior endplates. Data for measuring effective
T1 and T2 relaxation constants were calculated from a
series of images acquired with a minimum of 8 relaxation
delays. In each ROI, T1 and T2 values were computed as
quantitative measures of small molecule (gadodiamide)
diffusion through the endplates into the intervertebral disc
and water content, respectively.54,55 Values from loaded
discs were compared to non-loaded adjacent levels and
aged matched controls. Figure 2: Mid-sagittal μCT scans were used to measure
disc space height, endplate thickness, and subchondral
bone density in all specimens.
51
Table 1: Transverse axial MRI images were used to measure intervertebral disc cross-sectional area. Based on slight
variations in disc size, mean applied stress ranged from 2.56 to 2.95 MPa.
Treatment Group Applied Load (N) Mean Disc Area (cm2) Calculated Stress (MPa)
Sx Control 0 0.86 Not Loaded
0.5 Hz 10 wk 220 0.86 2.56
0.5 Hz 26 wk 220 0.75 2.95
5.0 Hz 8 wk 220 0.83 2.65
5.0 Hz 30 wk 220 0.79 2.74

and NP tissue using trizol extraction followed by Qiagen Serial Plain Radiographs
mini-prep kit utilizing a DNAse step to remove genomic Plain radiographs proved to have limited sensitivity for
DNA. Gene expression analysis (real time PCR) was subtle changes in disc space height. There were no statisti-
performed on the NP and AF using custom designed, cally significant changes (p>0.05) in DHI discernable from
validated primers to compare expression of inflammatory plain x-rays in either the high or low frequency loaded
genes (TNF-α, and IL-1β) and genes involved in matrix discs at any time point relative to baseline. In all loaded
homeostasis (Col I, Col II, aggrecan, versican, TIMP-1 levels, the mean change in disc height up to 30 weeks was
and MMP-3). The ∆∆Ct method was utilized to calculate less than 10%. X-rays did indicate osteophyte formation
relative gene expression after normalizing to the house- adjacent to the endplates of some animals subjected to
keeping gene GAPDH. long term (30 weeks) high frequency (5.0 Hz) loading as
shown in Figure 3.
Histopathology
Histologic analyses were used to assess cellular and tissue Post Contrast Enhanced T1 and T2 Mapping
level indicators of disc health and degeneration. Experi- T1 constants were higher (indicative of less gadodiamide
mental and adjacent unloaded motion segments were fixed diffusion) in loaded intervertebral discs relative to adja-
in 10% neutral buffered formalin and decalcified using a cent control levels. Data indicate increased T1 constants
7 day protocol (Formical 2000, Decal Chemical Corp., in the nucleus and anterior anulus of high frequency long
Tallman, NY). Decalcified specimens were routinely
processed, paraffin embedded, and sectioned serially in
the mid-sagittal and lateral para-sagittal planes. Speci-
mens were stained with either hematoxylin and eosin or
safranin-O and fast green. Discs were assessed qualita-
tively for lamellar organization and changes in structural
properties, proteoglycan content, cell morphology, cell
distribution, and fibrosis. The cartilaginous endplates were
assessed for thinning, ossification, disruption, and fracture.
Chondrocyte disorganization, clumping, and hypertrophy
were also assessed.

Results
Of the 11 animals in the study, all animals tolerated the
surgical procedure well. All were sufficiently acclimated
to the Degenerator so that none showed signs of distress
during loading and none required restraining. One poorly
placed transfixing pin failed at approximately 750,000
cycles (4 weeks) in the high frequency 8 week group and
the data from the animal were not included in subsequent
analyses. There were no other study related complications.
The mean disc cross-sectional area and corresponding disc
space stress for each group are shown in Table 1. Figure 3: Axial loading resulted in substantial disc
height loss in some animals.
52
Figure 4: Post contrast enhanced MRI indicated Figure 5: Post-contrast enhanced MRI imaging normal-
diminished diffusion in loaded levels (lower) relative ized to the sub-adjacent level indicated an increase in the
to unloaded adjacent levels (upper). T1 constant (decrease in gadodiamide) following 30 weeks
of high frequency loading (top). The corresponding T2
constants were reduced (bottom).

term animals, but no differences were detected in the increase in subchondral bone density at loaded levels
posterior annulus. More subtle differences were detected proposal to duration and frequency of exposure. After
in low frequency long term animals. Analysis of endplates 10 weeks of low frequency loading, subchondral bone
indicated a 10.5% decrease in T1 constants (increase in density increased by a mean of 11.9% and by 30 weeks
gadodiamide) in the caudal endplate relative to the non- of high frequency loading, bone density increased by
loaded surgical control, as shown in Figure 4. The high 20.6% compared to the sub-adjacent unloaded level as
frequency long term group also showed trends of decreased shown in Figure 6.
T2 constant in the nucleus, indicative of a reduction in
water as shown in Figure 5. Gene Expression Analysis
Data from a limited sample of NPs indicate a frequency ef-
Micro CT Analysis fect and duration effect with early (10 week) low frequency
CT analysis revealed that cyclic loading resulted in an (0.5 Hz) samples illustrating a reduction in expression

Figure 6: There was a 12% increase in caudal endplate subchondral bone density resulting from 10 weeks of low
frequency cyclic loading (left). Bone density increased by 21% in motion segments exposed to high frequency
loading for 30 weeks (right).
53
Figure 7: Mid-sagittal sections of surgical control (upper left), 26 week low frequency (upper right), 30 week high
frequency (lower left), and 48 week static load (lower right) were stained with safranin-O and fast green to assess
disc morphology and matrix organization. All images are 2X.

of versican and an increase in Col II accompanied by a and clustering in the nucleus, accompanied by matrix
dramatic reduction in Col I, TNF-α, IL-1β, MMP-3 and disorganization and a loss in disc height.
TIMP-1 relative to unloaded levels. Early (8 week) high Analysis of endplate cartilage and subchondral
frequency (5.0 Hz) samples illustrated a slight increase in bone indicated that unloaded surgical control endplates
expression of IL-1β and TIMP-1, with a slight reduction in have a distinct border with the adjacent subchondral bone.
COX-2, ADAMTS5, and MMP-3. Late (26 week) low fre- There are resting chondrocytes near the nucleus side and
quency samples indicate an increase in versican and Col II. relatively sparse hypertrophic chondrocytes on the bone
In contrast, late (30 week) high frequency (5.0 Hz) samples side. With loading, there is evidence of chondrocyte
express an increase in aggrecan and Col II accompanied cloning and hypertrophy. The cartilaginous endplates
by an increase in TNF-α, MMP-3, and TIMP-1. are thinned while the subchondral bone is thickened. As
Data from the low frequency AF samples indi- shown in Figure 8, the bony side of the cartilage is more
cate an initial pro-inflammatory response with dramatic diffusely integrated with bone and there are more numer-
increases in iNOS and IL-1β expression at 10 weeks, fol- ous hypertrophic chondrocytes present.
lowed by apparent remodeling at 26 weeks as indicated
by a decrease in all pro-inflammatory markers and a Discussion
sharp increase in Col II expression. Relative to unloaded We have developed an apparatus, atechnique, and an ani-
adjacent controls, high frequency AF samples indicated mal model to study the long-term effects of mechanical
an early reduction in expression of all inflammatory and loading on the intervertebral disc, endplates, and subchon-
homeostatic genes followed by an upregulation in expres- dral bone in the lumbar spine in vivo. The model allows us
sion of all measured in the 30 week high frequency loaded to apply physiologic loading to an individual motion seg-
discs with the most substantial increase in expression of ment of the NZW rabbit and can be used to characterize the
Col II. effects of load magnitude, frequency, and duration on the
health and degeneration of the spine. For the current study,
Histopathology we utilized the NZW rabbit, but the technique is potentially
The NP of unloaded age-matched surgical control sections scalable to other species using a modified apparatus. The
were sparsely cellular with a gelatinous extracellular ma- model is unique in that it facilitates investigation of the
trix. Twenty-six week loaded low frequency sections indi- earliest effects of mechanical loading at the molecular,
cated fibrosis and increased cell density in the NP. Thirty cellular, tissue, and global scale of both the intervertebral
week loaded high frequency sections showed advanced disc and endplates in the lumbar spine.
fibrosis, cell clustering, significant matrix disorganization, Unlike anular puncture models and chemonucle-
and disc space narrowing. olysis models which presuppose that degeneration is
As shown in Figure 7, relative to an age-matched initiated by anular failure or disc matrix changes,22,23 re-
unloaded surgical control disc, 30 weeks of high frequency spectively, the model utilized in the current study is based
loading has a deleterious effect on the disc. Loaded discs on mechanical loading alone with no assumptions on the
exhibited substantial fibrosis and increased cell number mechanism of degeneration. Likewise, previous models
54
Figure 8: In unloaded levels (left), the disc side of the cartilaginous endplate is comprised primarily of resting
articular chondrocytes (RC). In loaded levels (right), there is evidence of clustered hypertrophic chondrocytes (HC)
and endochondral bone formation with no distinct tidemark. 20X.

for studying the role of endplate diffusion in disc degenera- specimens, we measured an increase in subchondral bone
tion are based on iatrogenic alteration of the endplates or density and an increase in uptake of MRI contrast agent in
subchondral bone.56,57 In the current study, no disruptions the subchondral bone, indicative of sclerotic changes to the
were made to the loaded disc, endplates, or subchondral endplates in response to loading. In the same specimens,
bone, which uniquely facilitated study of the early effects there was a decrease in contrast agent into the disc. This
of mechanical loading on the lumbar spine. suggests a reduction in passive diffusion from the subchon-
Like the rat caudal vertebrae model, our results dral capillaries to the disc. Endplate histology corroborated
indicate that physiologic mechanical loading alone these findings, indicating thickened mineralized endplates
will initiate degenerative changes in the intervertebral in specimens exposed to prolonged loading. As shown in
disc.18-21 Unique to our model, we have also shown that Figure 9, the correlation suggests that mechanisms affect-
the endplates respond to loading with increasing bone ing subchondral bone density also potentially affect disc
density and endplate thickness. Because of the critical diffusion and homeostasis. This has been demonstrated
role of the endplates in disc homeostasis, characterizing previously in an unstable cervical spine injury model.58
the complex interrelationship between disc and endplate Gene analyses demonstrated substantial changes
pathology is critical in defining the mechanism of spinal in expression of loaded levels compared to adjacent
degeneration. unloaded controls in the NP and AF. Although the exact
In this pilot study, the significance of the results interpretation of these results is hampered by the small
is hampered by the small sample size. In cyclically loaded sample size, the observed trends suggest that the slower

Figure 9: Among all surgical levels, there is a correlation between T1 constant and subchondral bone density.
55
accumulation of load cycles in the low frequency group loading, diffusion, and disc degeneration remains unclear.
may have a beneficial effect on matrix homeostasis and But our preliminary data support the hypothesis that load-
inflammation in our model, whereas the rapid accumula- ing results in subchondral sclerosis, decreased diffusion,
tion of cycles in our high frequency group may stimulate and ultimately disc degeneration. Characterization of the
matrix synthesis accompanied by pro-inflammatory and temporal sequence of these events, the mechanism un-
catabolic activity. Loading at specific frequencies and derlying degeneration, and the dose response of the spine
magnitudes may have a protective effect, upregulating to mechanical loading may provide insights into future
anabolic activity and initiating remodeling rather than strategies for novel preventative measures, diagnostic
chronic degeneration.41,43,59 assessments, and therapies targeting low back pain. The
Based on our preliminary data, the mechanism novel we have developed can uniquely facilitate future
of disc degeneration and the relationship between cyclic work in these critical areas.

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59
The Effect of Anti-Rotation and Anti-Cutout Features in Cephalomedullary Nail Fixation of
Intertrochanteric Femur Fractures: An Acute Biomechanical Study
*Matthew W. Connelly, MS, **Jared Roberts, MD, †Rosemary Buckle, MD, *Eric H. Ledet, Ph.D.
* Department of Biomedical Engineering, Rensselaer Polytechnic Institute, Troy, NY.
** Division of Orthopaedic Surgery, The Albany Medical College, Albany, NY.

Orthopaedic Associates, LLP, Bellaire, TX.

Background: Extra-capsular hip fractures are common in the elderly population. Cutout, loss of fixation, and
proximal fragment rotation remain as possible complications of treatment with cephalomedullary nails. The pur-
pose of this study was to biomechanically compare two cephalomedullary nails that incorporate anti-rotation and/
or anti-cutout features to a previous generation nail with no such features.

Methods: The Gamma 3 Nail with standard lag screw was used as the benchmark for comparison to the Gamma
3 RC Clip nail and the Trigen InterTAN nail, both of which incorporate anti-cutout and anti-rotation features. An
intertrochanteric fracture was created in composite bone models. Each specimen was loaded to simulating single
leg stance 1,000 times while stiffness, migration (cutout), compressive force across the fracture site, and distal
fragment rotation were monitored.

Results: Maximum lag force during compression was very dynamic, highly variable, and decreased rapidly. Stiff-
ness was highest in the Trigen InterTAN group and mean migration of the proximal fragment was maximum in the
InterTAN group and least in the Gamma 3 group. Proximal fragment rotation was small for all constructs.

Conclusions: In the dense bone of the composite specimens, the enhanced designs of the Gamma 3 RC and the
InterTAN yielded little improvement relative to the Gamma 3. The stiffer InterTAN resulted in higher migra-
tion likely because a stiffer construct will cause compaction of bone around the lag screw. Additional research
in osteopenic bone is necessary to comprehensively characterize the effects of the design enhancements of these
implants.

Introduction: Cephalomedullary devices initially gained popularity for


Extracapsular hip fractures are common in the elderly treatment of unstable fractures but have now become a
population. In 2004, an estimated 756,000 proximal femur suitable option for even the stable intertrochanteric frac-
fractures occurred in the United States.1 That number ture. Mechanically, implant strains are decreased with
is increasing, and estimates suggest that four out of ten intramedullary fixation of intertrochanteric fractures
women over age 50 in the United States are likely to ex- relative to dynamic side plates and sliding screw fixation.7
perience a hip, spine, or wrist fracture sometime during However, cutout, loss of fixation, and proximal fragment
the remainder of their lives.2 Hip fractures in the elderly rotation remain as potential complications of treatment
population are associated with a three times greater risk with cephalomedullary nails.8-11 The latest generation of
of mortality during the first three months after fracture nails are designed to minimize cutout and incorporate
compared to non-fractured cohorts.3,4 Nearly one in five hip anti-rotation features in the design. These design features
fracture patients ends up in a nursing home and mortality purport to minimize loss of fixation and result in better
after hip fracture is around 30% at one year.5 Prevention outcomes. Several intramedullary products are currently
and treatment of hip fractures has thus become a national available to the orthopaedic surgeon, however, the relative
priority.6 performance characteristics of these implants have not
Despite significant improvements in both surgery been reported and to date there have been no comprehen-
and rehabilitation in recent decades, hip fracture treatment sive reports on the biomechanics of the latest generation
remains a challenge. Treatment options for extracapsular nails compared to previous designs.
hip fractures include extramedullary devices such as com- The purpose of this study was to compare two
pression hip screws or cephalomedullary devices. Until cephalomedullary nails that incorporate anti-rotation and/
recently, the compression hip screw was the gold standard or anti-cutout features to a previous generation nail with
for intertrochanteric fractures, both stable and unstable. no such features with respect to fracture compressive lag

Acknowledgements: This study was funded by an institutional grant from Stryker.


60
force, bending stiffness, migration, cutout, and proximal were randomly assigned to receive either the 125° Gamma
fragment rotation using biomechanical testing in an inter- 3 Nail (180 mm long with 10.5 mm ɸ x 95 mm standard
trochanteric in vitro fracture model. lag screw) in the “G3S” group, the 125° Gamma 3 RC Clip
Nail (180 mm long with 10.5 mm ɸ x 95 mm lag screw
Materials and Methods and clip) in the “G3RC” group, or the 125° InterTAN Nail
The Gamma 3 Nail with standard lag screw (Stryker, with compression screw (180 mm long with 11 mm ɸ x 95
Mahwah, NJ) was used as the benchmark for comparison mm lag screw and 7 mm ɸ x 90 mm compression screw)
to the Gamma 3 RC Clip nail (Stryker, Mahwah, NJ) and in the “ITI” group. A sample size of six (n=6) was used
the Trigen InterTAN nail with compression screw (Smith for each treatment group for a total of 18 specimens.
& Nephew, Memphis, TN). As shown in Figure 1, both Implants were placed according to each manu-
the Gamma 3 RC Clip nail and the Trigen InterTAN nail facturer’s recommended technique with every attempt
incorporate anti-rotation and/or anti-cutout features not made to position the lag screws so that the final tip to
found in previous nail designs. apex distance was less than 25 mm as recommended by
To evaluate the biomechanical performance of Baumgaertner.9 Pilot holes for placement of the nails and
the nails, Evans Type I stable intertrochanteric fractures the lag screws were drilled using a drill press and custom
were created in fourth-generation composite Sawbone jigs to minimize variability in placement technique. Sub-
left femurs (Pacific Research Laboratories, Vashon, WA). sequently, implants were placed using standard techniques
The composite bones have similar properties to healthy with each manufacturer’s instruments. The lag screws
human bone.12-14 were placed across the partial osteotomy extending sev-
All specimens were prepared in identical fashion. eral turns into the femoral head but were not advanced
Using a jig for repeatability, a bandsaw was used to create a completely into the proximal fragment. Using a bandsaw,
partial intertrochanteric osteotomy centered proximally in the osteotomies were then completed without the blade
the greater trochanter and extending distally to the center touching the lag screw. The proximal fragment was then
of the lesser trochanter. removed by carefully unscrewing it from the lag screw.
Before completing the osteotomy, the femurs A second osteotomy was cut from the proximal fragment

Figure 1: The lag screws used with the Gamma 3 RC Clip nail (center) and the Trigen InterTAN nail (right) incorpo-
rate anti-rotation and/or anti-cutout features not found in previous nail designs such as the Gamma 3 nail (left).

61
Figure 3: Posterior view images were used to gauge
movement of the proximal fragment relative the femoral
shaft. Compression forces across the fracture site (in-
Figure 2: All specimens underwent an identical proce- dicated by arrows) were measured via a load cell array
dure to create a 5 mm osteotomy. placed in the osteotomy gap.

parallel to the first resulting in a 5 mm thick section of After a one minute quiescent period, a high
intertrochanteric bone being removed. The proximal frag- resolution digital photograph was taken of the proximal
ment was then carefully placed back onto the lag screw femur from a posterior view with a scale marker positioned
in a position identical to when it was removed. This fa- within the image for reference, as shown in Figure 3. Ad-
cilitated anatomic reduction of each fracture with a 5 mm ditional “flag” pins were placed in the proximal and distal
osteotomy and minimized variation between specimens fragments extending posteriorly to monitor any rotation of
as shown in Figure 2. the proximal fragment during loading. A high resolution
To measure compressive lag force across the digital photograph was taken of the femur from a lateral
osteotomy site, an array load cells was placed in the os- view with the markers positioned within the image for
teotomy gap. Three 3.5 mm thick button load cells (Futek reference, as shown in Figure 4.
Advanced Sensor Technology, Inc., Irvine, CA) were fixed After baseline (no load) images were taken, the
between two aluminum plates so that the overall thick- crosshead of the mechanical testing machine was lowered
ness of the sensor array was 5 mm. The sensor array was and zeroed at the point of contact with the femoral head.
placed into the osteotomy gap around the lag screw so A flat loading platen attached to the crosshead was used
that the three sensors were located proximal to the screw, to apply a vertical compressive load to the femoral head.
anterodistal to the screw, and posterodistal to the screw. The platen was attached to a roller plate to allow uncon-
The sensor array allowed free passage of the lag screw strained motion of the femoral head under axial loading.
into the femoral head, as shown in Figure 3. The specimen was then loaded to 750 N simulating single
Before tightening the lag screws, the distal third leg stance17-19 and unloaded back to zero at a rate of 25
of each femur was cut off, the nails were locked distally, mm per minute while fracture compression force data,
and the specimen was potted vertically using quick setting mechanical testing machine force data, and crosshead
epoxy (Bondo, Atlanta, GA) in an aluminum cup. The displacement data were collected. At peak load, posterior
cup was mounted to a fixture and placed in a mechanical and lateral view photographs were taken for later assess-
testing machine (MTS Systems, Carry, NC) so that it was ment of deformation/relative motion. After unloading, the
oriented at 25° adduction in the coronal plane and neutral specimen was again photographed from both posterior and
in the sagittal plane.15-17 lateral directions. Each specimen was then cycled 1,000
Once mounted in the mechanical testing ma- times from 50 to 750 N. At 10, 100, 250, 500, 750, and
chine, the lag screws were inserted completely into the 1,000 cycles, data were recorded and each specimen was
distal fragment, extending through the sensor array into photographed at peak load and after unloading to monitor
the femoral head. The lag screws were then compressed stiffness, changes in femoral head displacement (migra-
2.5 mm one half screw turn at a time while compressive tion), compressive force across the fracture site, and distal
force data were recorded from the sensor array at a rate fragment rotation.
of at least 10 samples per second.
62
Figure 4: Image analysis and two pins were used to Figure 5: Tip to apex distance (arrow) was measured
determine the amount of proximal fragment rotation from the proximal fragment using the technique pro-
relative to the fixed distal component. posed by Baumgaertner9 after sectioning with a bandsaw.

Migration, defined as extent of the residual were compressed to 2.5 mm and completed the testing
collapse of the proximal fragment after removal of load protocol with no device related complications.
at each cycle, was measured using the crosshead of the
mechanical testing machine. After completion of each Compressive Lag Force
measured loading cycle, the difference between the Maximum lag force during compression was very dynamic
baseline location of the crosshead and the femoral head and highly variable. As shown in Figure 6, the force
was measured. Residual femoral head displacement (mi- was highly time dependent and decreased rapidly. The
gration) was compared between treatment groups at all mean maximum compressive force during lagging was
loading cycles. highest in the G3S group followed by the G3RC group
After completion of cyclic testing, the sensor followed the ITI group, as shown in Figure 7. There was
array was removed and the proximal fragment was un- no significant difference in mean maximum force between
screwed from the lag screw. The proximal fragment was G3S and G3RC groups after compression, but both were
sectioned using a bandsaw and the tip to apex distance significantly higher than the ITI group (p<0.002).
was measured using a caliper, as shown in Figure 5. After a single loading cycle, there was a substan-
Photographs were analyzed digitally (ImageJ, NIH) to tial loss in compressive force in all treatment groups. The
determine proximal fragment rotation about the lag screw. compressive force across the osteotomy gap dropped to
Compressive lag force across the osteotomy was analyzed less than 10% of the peak value by completion of the first
at cycles 1 through 100. Stiffness of each construct was cycle. The ITI and G3RC groups maintained the highest
calculated from the linear region of the force-displacement forces after the first cycle, with the G3S group dropping
curves from the mechanical testing machine. Quantitative to near zero by cycle 100. There were no statistically
data were compared between the three treatment groups significant differences between treatment groups at any
using an ANOVA and Games-Howell post-hoc testing with time after the initial lag likely due to the high variability
values considered statistically significant at p<0.05. in the readings, as shown in Figure 7. Continued cyclic
loading did affect the magnitude of the compressive force
Results across the osteotomy with some cycles resulting in a slight
All of the implants were placed in a similar fashion us- increase in force.
ing the custom jigs. Due to the density of the composite
bone models (simulating healthy bone), compression of Construct Stiffness
the lag screws was very difficult in all specimens and Construct stiffness was calculated from the linear portion
hand tools (pliers) were necessary to rotate the lagging of the load/crosshead displacement curve. The mean stiff-
apparatus. Compression beyond 2.5 mm would likely ness was highest in the ITI treatment group at all cycles,
have been impossible in this model. One specimen (in as shown in Figure 8. The mean stiffness of all constructs
the G3S group) cracked during testing. This specimen increased with cycles. The differences in stiffness between
was the first tested and an initial attempt had been made treatment groups were not significant at the first cycle of
to compress it beyond 2.5 mm. The specimen was likely testing, but the difference between the ITI stiffness and the
damaged during compression and subsequently it was not other two treatments approached significance by the 10th
used in the analysis after it cracked. All other specimens cycle (p<0.09). Mean ITI stiffness became significantly
63
Figure 6: Compressive force was measured as the lag screw was used to compress the osteotomy.

Figure 7: The mean maximum compressive force during lagging was significantly higher in the G3S and G3RC
groups compared to the ITI group, but the force diminished substantially for all groups by completion of the first
cycle of loading. Error bars indicate on standard deviation.
64
Figure 8: The mean stiffness was highest in the ITI treatment group at all cycles and was significantly higher than
the G3S and G3RC groups at cycles 100 through 1000. Error bars indicate on standard deviation.

higher from the 100th to 1,000th cycle (p<0.038). There the other two treatment groups, but there were no signifi-
were no significant differences between the G3S and cant differences between the G3S and G3RC groups.
G3RC groups at any cycle.
Discussion
Proximal Fragment Rotation The Gamma 3 RC nail incorporates a clip that slides over
The proximal fragment rotation was small for all con- the lag screw and flares out at the medial end of the screw
structs. The maximum mean rotation of any construct was after it has been placed. The Trigen InterTAN nail incor-
1.8°, measured in the G3S group after cycle 250. Although porates a second compression screw that interlocks with
the rotation of the G3S group was at least three times the lag screw. The addition of these features is intended
higher than the other groups at every measured cycle, the to reduce proximal fragment rotation and cutout. Both
differences between groups were not statistically signifi- designs add to the complexity and cost of the systems
cantly different at any cycle number, likely due to the high relative to more traditional nails that do not incorporate
variation in specimens, as shown in Table 1. such features. In this study, we evaluated the effects of
the enhanced design features of the latest generation of
Migration cephalomedullary nails relative to the more traditional
There was no cutout in any specimen and migration of design of the Gamma 3 Nail. To evaluate the effects on
the lag screw within the femoral head was minimal for the biomechanical properties, we used a physiologically
all treatment groups. At every measured cycle, mean relevant model of hip biomechanics to simulate the acute
migration was maximum in the ITI group and least in post-operative phase of loading.
the G3S group. Mean migration ranged from 1.2 to 2.3 Our results indicate that all of the systems are
mm as shown in Figure 9. There were no statistically capable of generating substantial compressive force to
significant differences in cutout between any treatments lag a fracture intra-operatively. The G3S and G3RC
at any measured cycle. nails generated over 800 N of compressive force in the
dense bone of the composite models. This force is ample
Tip to Apex Distance for reduction and compression of most intertrochanteric
Mean tip to apex distance for each treatment group is fractures.20 However, the compressive force was imme-
shown in Table 1. The tip to apex distance was statistically diately lost and dropped to less than 10% of its peak after
significantly (p<0.002) lower in the ITI group compared to a single cycle of loading. This indicates that while the
65
Table 1: Proximal Fragment Rotation and Tip to Apex Distance

G3S ITI G3RC


Mean Stdev Mean Stdev Mean Stdev
Rotation Cyc 1 [°] 1.2 1.3 0.4 0.2 0.4 0.2
Rotation Cyc 10 [°] 1.2 1.5 0.4 0.3 0.3 0.4
Rotation Cyc 100 [°] 1.6 2.1 0.4 0.3 0.4 0.3
Rotation Cyc 250 [°] 1.8 2.5 0.4 0.3 0.2 0.3
Rotation Cyc 500 [°] 1.8 2.4 0.5 0.3 0.3 0.3
Rotation Cyc 750 [°] 1.6 1.9 0.4 0.2 0.4 0.3
Rotation Cyc 1,000 [°] 1.5 1.8 0.5 0.3 0.4 0.3
TAD [mm] 34.1 1.4 16.9 2.2 33.4 6.1
TAD, tip to apex distance.

implants are effective at lagging the proximal fragment nail is designed to allow shortening of the fracture under
intra-operatively, none are capable of maintaining the load to allow bone impaction and facilitate increased
compression under the loads associated with single leg stability at the fracture site.21 All three implants used in
stance. The G3S system was able to generate the highest this study have set screws which hold the lag screw in
mean compressive force, but resulted in the lowest com- the nail. While the set screws appear to be effective at
pressive force following one cycle of loading and dropped preventing rotation of the lag screw relative to the nail, all
to zero compressive force by cycle 100. The other two three systems allow dynamic sliding of the screw when the
systems were not able to generate as much compression, femur is loaded, even when the set screws are tightened.
but were able to maintain some compression through the Our results indicate that the set screws are sufficient to
first 100 cycles of loading. maintain the relative position of the lag screw while the
Like the sliding hip screw, the cephalomedullary proximal fragment is lagged into place, but the set screws

Figure 9: Mean migration in all treatment groups was less than 2.5 mm and reached a plateau by 750 cycles.

66
do not facilitate “locking” of the lag screw relative to the the screw under load and local compaction of the bone
nail. Our results also indicate that the ability of each sys- around the screw. Compaction of the bone results in a void
tem to lag the proximal fragment is not dependent on the adjacent to the screw and settling.11 The more stiff the lag
novel design features (the clip or interlocking compression screw is relative to the adjacent bone, the more relative
screw), however the new designs do appear to facilitate deformation will occur and the more compaction and
some retention of compression under load. It is not clear migration will result. As the bone becomes compacted,
from this study what feature in the new designs enhances its local stiffness increases and migration plateaus with
maintenance of fracture compression. increasing cycles. In osteopenic bone, the effects of a mis-
Proximal fragment rotation was small for all match in stiffness will be increased and further migration
constructs. The amount of friction between the lag screw or cutout is more likely.
and the proximal fragment was high for all specimens Among other factors, the likelihood of cutout in
based subjectively on the amount of torque necessary the treatment of peritrochanteric fractures is dependent
to advance and compress the lag screw. Mean proximal on surgical technique.8,9 Tip to apex distance is strongly
fragment rotation was highest in the Gamma 3 Nail group. correlated to incidence of cutout with 25 mm being a
However, the maximum rotation in this group was 1.8° threshold value above which cutout is more likely.9 In
and is still within an acceptable range for clinical practice. this study, every attempt was made to size and place the
The enhanced designs of the Gamma 3 RC and the Trigen implants to achieve a tip to apex distance of less than 25
InterTAN resulted in negligible rotation in all specimens mm. However, a post-hoc measurement revealed that the
(mean less than 0.5°), a substantial reduction in rotation mean tip to apex distance in two of the three treatment
relative to the traditional design. In osteopenic bone, it is groups (G3S and G3RC) was greater than 25 mm while
likely that proximal fragment rotation would be greater in the third group (ITI) was less than 25 mm. This inherently
all cases and that the advantages of the enhanced designs predisposes two treatment groups to a higher likelihood
would be more prominent.17 of cutout and thus is a confounding factor in this study.
Rigid fixation and ample implant stiffness are However, as shown in Figure 10, a regression analysis of
critical for minimizing interfragmentary motion and main- all specimens correlating tip to apex distance and migration
taining fracture reduction under load.22 In this study, the indicated only a very weak correlation (R2=0.10) indicat-
InterTAN nail constructs had the highest stiffness of the ing that either the composite model bones or the implant
three implants. The addition of the interlocking compres- systems were insensitive to tip to apex distance within the
sion screw inferior to the lag screw increases the moment range of our testing.
of inertia of the construct and subsequently enhances its In this study, we used composite models to
bending stiffness.23 There was little difference in the stiff- simulate bone of normal density. In osteopenic bone,
ness between the Gamma 3 and the Gamma 3 RC nails the likelihood of cutout and proximal fragment rotation
indicating that the addition of the clip to the nail does not are higher and the benefit of the design features of the
significantly enhance bending stiffness. In all treatment nails warrants further assessment. The addition of the
groups, the mean stiffness increased with loading cycles, interlocking compression screw in the Trigen InterTAN
likely due to settling and compaction of the bone around implant appears to primarily increase the stiffness of the
the tip of the lag screw. device, whereas the addition of the clip in the Gamma 3
The trends in migration of the three treatment RC implant appears to primarily reduce proximal fragment
groups mirror the trends in stiffness with highest migra- rotation. In this study, both implants performed well with
tion in the InterTAN group. This is likely because a stiffer clinically acceptable levels of cutout and rotation. How-
construct will cause compaction of bone around the lag ever, additional research in osteopenic bone is necessary
screw. A large mismatch in stiffness between the bone and to comprehensively characterize the effects of the design
the implant will result in the bone deforming more than enhancements of these implants.

67
Figure 10: A regression analysis of all specimens indicates only a weak correlation (R2=0.10) between tip to apex
distance and migration.

References

1. American Academy of Orthopaedic Surgeons. The 5. Salkeld G, Cameron ID, Cumming RG, et al. Quality
Burden of Musculoskeletal Diseases in the United of life related to fear of falling and hip fracture in older
States. AAOS: Rosemont. 2008. women: a time trade off study. British Medical Journal.
2000;320(7231):341-6.
2. Cummings SR, Melton LJ. Epidemiology
and outcomes of osteoporotic fractures.Lancet. 6. United States Department of Health and Human
2002;359(9319):1761-7. Services. Bone health and osteoporosis: a report of
the surgeon general. Rockville, MD: U.S. Department
3. Leibson CL, Tosteson AN, Gabriel SE, Ransom JE,
of Health and Human Services, Office of the Surgeon
Melton LJ. Mortality, disability, and nursing home use
General, 2004.
for persons with and without hip fracture: a population-
based study. J Am Geriatr Soc. 2002;50(10):1644-50. 7. Rosenblum SF, Zuckerman JD, Kummer FJ, Tam
BS. A biomechanical evaluation of the gamma nail. J
4. Richmond J, Aharonoff GB, Zuckerman JD, Koval
Bone Joint Surg Br. 1992;74(3):352-7.
KJ. Mortality risk after hip fracture. J Orthop Trauma.
2003; 17(1):53-6.

68
8. Thomas AP. Dynamic hip screws that fail. Injury. 16. Kubiak EN, Bong M, Park SS, Kummer F,
1991;22(1):45-6. Egol K, Koval K. Intramedullary fixation of unstable
intertrochanteric hip fractures. One or two lag screws.
9. Baumgaertner MR, Curtin SL, Lindskog DM, Keggi
J Orthop Trauma. 2004;18:12-17.
JM. The value of tip-apex distance in predicting failure
of fixation of peritrochanteric fractures of the hip. J Bone 17. Strauss E, Frank J, Lee J, Kummer FJ, Tejwani.
Joint Surg Am. 1995; 77:1058-64. Helical blade versus sliding hip screw for treatment of
unstable intertrochanteric hip fractures: a biomechanical
10. Haynes RC, Poll RG, Miles AW, Weston RB. Fail-
evaluation. Injury. 2006;37:984-9.
ure of femoral head fixation: a cadaveric analysis of
lag screw cut-out with the gamma locking nail and AO 18. Taylor SJG, Perry JS, Meswania JM, Donaldson
dynamic hip screw. Injury. 1997; 28(5-6):337-41. N, Walker PS, Cannon SR. Telemetry of forces from
proximal femoral replacements and relevance to fixa-
11. Sommers MB, Roth C, Hall H, et al. A laboratory
tion. J Biomech. 1997;30(3):225-34.
model to evaluate cutout resistance of implants for
pertrochanteric fracture fixation. J Orthop Trauma. 19. Davy DT, Kotzar GM, Brown, RH, et al. Telemet-
2004;18:361-8. ric Force measurements across the hip after total arthro-
plasty. J Bone Joint Surg Am. 1988;70(1):45-50.
12. Heiner A, Brown T. Structural properties of a new
design of composite replicate femurs and tibias. J 20. Graham AE, Xie SQ, Aw KC, Mukherjee S, Xu
Biomech. 2001;34:773-82. WL. Bone–muscle interaction of the fractured femur.
J Orthop Res. 2008;26:1159–1165.
13. Chong ACM, Miller F, Buxton M, Friis EA.
Fracture toughness and fatigue crack propagation rate 21. Kyle RF, Wright TM, Burstein AH. Biomechanical
of short fiber reinforced epoxy composites for analogue analysis of the sliding characteristics of compression hip
cortical bone. J Biomech Eng. 2007;129:487-93. screws. J Bone Joint Surg Am. 1980;62(8):1308-14.

14. Chong ACM, Friis EA, Ballard GP, Czuwala PJ, 22. Kraemer WJ, Hearn TC, Powell JN, Mohamed
Cooke FW. Fatigue performance of composite analogue N. Fixation of segmental subtrochanteric frac-
femur constructs under high activity loading. Ann tures: a biomechanical study. Clin Orthop Rel Res.
Biomed Eng. 2007; 35(7):1196–1205. 1996;332:71-9.

15. Kummer FJ, Olsson O, Pearlman CA, Ceder L, 23. Gere JM, Timoshenko SP. Mechanics of Materials,
Larsson S, Koval K. Intramedullary versus extramedul- 3rd Edition. PWS Publishing: Boston. 1990.
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cal study. Acta Orthop Scand. 1998;69(6):580-4.

69
A New ACL Guide for Accurate Tunnel Placement
Jason Wong, Rachel Michos, Ryan Harting, Whitney Naslund
Advisors: R. Maxwell Alley, MD, Eric H. Ledet, Ph.D,

2010 Senior Design Showcase Finalist, Rensselaer Polytechnic Institute

The Problem: Design alternatives:


The accepted method of tunnel placement for ACL recon- • Hinge design
struction involves drilling a guide pin after locating the • Nitinol (shape memory metal)
exit point on the tibial plateau. If the original tibial guide
pin was placed too vertically, there will be a misalignment Final design concept:
as the pin is drilled through the femur. Slider design
• Marks the femoral and tibial ACL footprint simul-
Design Goals: taneously
Design a guide that allows the position of the tibial tunnel • Sliding track mechanism
to be determined using landmarks on both the tibia and the • Lever system
femur simultaneously prior to choosing the path through • Angle adjustment preserves linearity
for the guide through the tibia.

Figure 1: Concept drawing of the ACL Figure 2: Prototype of the hinged ACL guide.
guide.

Figure 3: Placement of the guide on a saw bones model.

70
Minimally Invasive Reusable Carpal Tunnel Release System
Jonathan Chung, Matthew Connelly, Courtney Dumont, Alyssa Kowcz, Jason Taylor,
Jeffrey Teixeira, Samantha Wozniak
Advisors: David E. Quinn, MD, Richard R. Whipple, MD, Eric H. Ledet, Ph.D

2010 Senior Design Showcase Finalist, Rensselaer Polytechnic Institute

The Problem: Design alternatives:


Current endoscopic carpal tunnel release systems exhibit Three tip designs considered before the final design are
limitations including having a limited range of view, re- presented in Figure 1.
duced visualization due to fogging and difficulty separat-
ing the tenosynovium. Final Design Concept:
• Replaceable blade
Design Goals: • Enhanced field of view
• Improve the visualization throughout the procedure • Improved tenosynovium stripping capabilities
• Maintain alignment with the ring finger axis (Figures 2 and 3)
• Minimize the number of non-reusable parts
• Reduce the number of procedure steps

Figure 1: Tip design evolution prior to the final design choice.

Figure 2: The final design choice showing the enhanced tenosynovium stripping edge.

Figure 3: Profile of the final design choice.

71
Albany Medical College
Division of Orthopaedic Surgery
Grand Rounds Presentations
Grand Rounds for the Division of Orthopaedic Surgery are presented every Wednesday (except the first Wednes-
day of the month), 7 AM to 8 AM EST (EDT), from the auditorium at the Bone and Joint Center, 1367 Washington
Avenue, Albany, NY.

Grand Rounds speakers include Division of Orthopaedic Surgery faculty and residents, and guest lecturers. Topics
are chosen to provide a broad coverage of current orthopaedic treatment as well as relevant clinical and basic science
topics.

Grand Rounds Schedule for 2010

DATE SPEAKER TOPIC

1/13/10 Brent Carlson, MD Shoulder Arthroplasty: Various Options & Indications

1/20/10 William Robb III, MD Advances in Prevention of VTE in Orthopaedics

1/27/10 Jared Roberts, MD Blounts Disease

2/17/10 Jeffrey Klauser, MD Acromioclavicular Joint Injuries

2/24/10 Ronniel Nazarian, MD History of Disc Replacement

3/10/10 Ricardo Valle, MD Treatment of 5th Metatarsal Fractures in Athletes

3/17/10 Jacqueline Vanderzanden, MD Flexor Tendon Repairs

3/24/10 Samuel Dellenbaugh, MD Upper Extremity Injuries in Little Leagers

3/31/10 Reginald Knight, MD Historic Overview & Recent Evidence for MIS Spine Surgery

4/14/10 Adam Suslak, MD Pediatric Knee Injuries

4/21/10 Christopher Palestro, MD SPECT/CT Applications in Orthopaedics

4/28/10 Paul Johnson, MD Health Care Reform

5/12/10 Scott Brotherton, MD The History of Orthopaedics

72
DATE SPEAKER TOPIC

5/19/10 Michael Flaherty, MD Ewing Sarcoma

5/26/10 Andrew Gerdeman, MD Alphabet Shoulder Soup

6/9/10 Matthew DiCaprio, MD Which Bone & Soft Tissue Tumors Can be Treated by

6/16/10 Joel Horning, MD Subtalar Dislocations

6/23/10 William Lavelle, MD Adult Lumbar Scoliosis

6/30/10 Bruce White, MD Ethical Dilemmas in Orthopaedics

73
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NOTES
NOTES
6901C Trauma Ad_Fullpg 2/1/07 3:32 PM Page 1

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