J Oral Maxillofac Surg

59:539-544, 2001

Mandibular Distraction Force: Laboratory

Data and Clinical Correlation
Randolph C. Robinson, MD, DDS,* Patrick J. ONeal, BS,
and Ginger H. Robinson, BSN, RN
Purpose:

In vitro data were collected to measure torque-force values of an internal distraction device.
The measurements were correlated with in vivo torque readings in an attempt to better understand the
force required to distract the osteogenic bone callus of the human mandible during distraction osteogenesis.
Methods and Materials: Five internal craniofacial distraction devices were mounted on an apparatus
to test load limits and torque measurements. The apparatus aligned the devices so that weight provided
a force opposite and parallel to the vector of distraction. Weights were added in 5-lb increments, and the
devices were activated 0.5 mm for each torque reading. Torque readings were obtained from a calibrated
torque wrench. Measurements were plotted on a graph and correlated with clinical torque readings
obtained from 8 patients undergoing mandibular lengthening.
Results: The average torque for distracting the human mandible 0.5 mm twice a day was 4.2 1.6
Newton-centimeters (N-cm). The average slope of the in vitro data shows that 4.2 N-cm of torque is
equivalent to a force of 35.6 N. The average force of device failure was 235.8 N.
Conclusion: Torque-force diagrams offer an effective means for calibrating safety margins and load
capabilities for internal distraction devices. Quantification of axial forces encountered in mandibular
lengthening will help contribute to the overall understanding and biomechanics of mandibular distraction osteogenesis.
2001 American Association of Oral and Maxillofacial Surgeons
change in velocity of an object. The unit of force in
the metric system is the Newton (N). A Newton is that
force which, when applied to a 1 kg mass, gives it an
acceleration of 1 m/s/s. Therefore:
1 N 1 kg 1 m/s2 1 kg m/s2
1 lb 4.45 N
Torque is the force needed to cause a rotational
movement and is measured in Newton-meters or
Newton-centimeters (N-cm). Because most distraction devices use a threaded drive shaft to move the
ends apart, clinical measurements of torque are the
easiest to make. However, although torque is reflective of the load on the device, it is not a direct
measure of the distraction force at the osteotomy site.
Torque is a factor of the coefficient of friction of the
materials, the diameter of the drive shaft, and the
pitch angle of the threads in the gears, the surrounding soft tissue, and the bone callus. Therefore, torque
measurements are specific to a particular device, and
so it is necessary to establish the relationship between
the torque and the load for each device design. This
relationship is the slope of the line when a load is
plotted on the x axis and torque is plotted on the y
axis. This linear correlation can be used to indirectly
measure the force of distraction at the bone level for
a given torque observed during activation. This information can then be used in the clinical setting to

Distraction osteogenesis is becoming more common for reconstruction of facial bone deficiencies.
However, it is difficult to quantify the forces necessary to distract the active reparative bone callus
in the human during this process. Therefore, a
study of an internal distraction device is needed to
determine the torque-force values for the facial
bones, failure load limit requirements, and correlation of these in vitro measurements with those
found in clinical cases.
Force is the mass times the acceleration (F ma).
In other words, force is the influence to cause a
*Chief of Oral and Maxillofacial Surgery, Saint Joseph Hospital,
Denver, CO.
Director of Research and Development, Inter-Os Technologies,
Inc, Lone Tree, CO.
Nursing Researcher, 3110 Enterprises, Centennial, CO.
Dr Robinson is President of Inter-Os Technologies, Inc and Mr
ONeal is Director of Research and Development at Inter-Os Technologies, Inc, Lone Tree, CO.
Address correspondence and reprint requests to Mr ONeal:
7430 E Park Meadows Dr, Suite 300, Lone Tree, CO 80124; e-mail:
patrick.oneal@interos.com
2001 American Association of Oral and Maxillofacial Surgeons

0278-2391/01/5905-0010$35.00/0
doi:10.1053/joms.2001.22688

539

540

MANDIBULAR DISTRACTION FORCE

FIGURE 2. The distraction device fixed on the mandible. Each

fixation plate has 3 holes for screw fixation. Each plate may be
removed or manipulated to accommodate bone contour and different
vectors of device placement.

FIGURE 1. Bone Generator internal craniofacial distraction device.

Device closed down with activation pin attached (top). Device opened
with activation pin removed (bottom).

determine the safety margins for device manufacturing and to give immediate clinical feedback regarding
what may be happening in the distraction site (eg,
premature consolidation, device failure, or incomplete osteotomies). This information can then be used
to determine if the rate, rhythm, or distance of distraction should be modified. It can also indicate if
additional radiographs should be taken, if an exploration should be made, or if the device should be replaced.
Even though distraction osteogenesis of the mandible is well reported in the literature,1-17 no study has
been published describing the force necessary to distract the human mandible. The purpose of this article
is to report laboratory data on the torque-force measurements of an internal craniofacial distractor, the
Bone Generator (Inter-Os Technologies Inc, Lone
Tree, CO) and to correlate the data to clinical cases of
mandibular distraction with the same device (Figs 1,
2). The study also measured device load limits to
failure and related the results to an overall margin of
safety for internal distraction.

vertical load provided a force opposite and parallel to

the vector of distraction. The device was lubricated
with 1 to 2 drops of mineral oil in a similar manner as
in the clinical setting and was opened and closed 2 to
3 times to ensure lubrication of the internal gears. The
first torque measurements of each device were made
with the suspension wire apparatus only, which
weighed 3 lbs. The torque wrench (Seebonk Inc,
Seebonk, MA) used a spring scale ranging from 0 to 24
inch-ounces. Mounted on the end of the torque

Methods and Materials

IN VITRO STUDY

Five Bone Generators (Inter-Os Technologies Inc,

Lone Tree, CO) were mounted on a custom-designed
vice and apparatus to hold them in a vertical orientation. A level was used to confirm the position. Suspension wires from a horizontal steel bar were attached to the movable part of the device so that a
vertical load could hang below the device (Fig 3). The

FIGURE 3. Axial loading apparatus. Devices were loaded in 5-lb

increments and tested until failure.

541

ROBINSON, ONEAL, AND ROBINSON

lateral and bilateral lengthening of the mandible. The

study involved 8 patients (1 male, 7 females), whose
ages ranged from 6 to 20 years of age at the time of
distraction. The clinical indications for distraction osteogenesis were bilateral mandibular hypoplasia (n
4), mandibular hypoplasia with condylar agenesis
(n 2), oral-facial-digital syndrome (n 1), and
hemifacial microsomia (n 1). Distraction commenced 6 days postoperatively at a rate of 0.5 mm
twice a day until the desired length was achieved.
Total distraction distances ranged from 4 to 17 mm,
with a mean lengthening distance of 11.2 mm. Torque
measurements were taken with the same torque
wrench that was used in the in vitro laboratory setting
(Fig 4).

FIGURE 4. Patient undergoing 0.5 mm of distraction while the torque

is measured.

Results

wrench was an activation wrench used to activate the

device in the clinical setting. The device was turned 2
full revolutions, or 0.5 mm of distraction, and the
average observed torque measurement was made and
recorded. The device was closed back down to its
original position after the load was removed. Loading
and torque measurements proceeded in 5-lb increments up to 28 lbs (including the 3 lb suspension
apparatus). The measurements were then plotted, a
torque/force line was drawn for each of the 5 devices,
and an average slope was established.
After the measurements were made to 28 lbs, each
device was progressively loaded in 5- or 10-lb increments until failure. This process was carried out by
activating the device for 1 full millimeter or 4 full
turns using the activation wrench. Care was given to
maintain the vertical orientation because of the lateral
load limits. After each test, the weight was removed
and the device was closed back to its original position.

IN VITRO DATA

All devices tolerated the torque measurements up

to 28 lbs. The endpoint for torque measurements for
the tests was determined by the limits of the torque
wrench, which was over 24 inch-ounces. Measurements up to 28 inch-ounces could be made by reasonable continuation of the scale on the torque
wrench. The measurements were converted from
inch-ounces to Newton-centimeters and recorded on
a spreadsheet on a laptop computer (Table 1). A
graph was then created using the graphing portion of
the spreadsheet program (Fig 5).
The devices all failed at load limits of 48 lbs or
above, except for one. This device failed at 38 lbs
because of a lateral shift that occurred during loading
of additional weight. Two of the devices sustained 58
lbs, and one device sustained 63 lbs. Failure occurred
at an average load of 53 10 lbs. The average load at
failure, excluding the device that failed because of a
loading error, was 56.8 lbs 6.3 lbs (SD).

IN VIVO STUDY

IN VIVO DATA

The correlative torque data taken from the clinical

trials involved patients who underwent mandibular
distraction osteogenesis using the Bone Generator.
Fourteen distraction devices were used for both uni-

Torque measurements from the clinical trials are

shown in Table 2. The average torque for distracting
the human mandible 0.5 mm twice a day was 4.2

Table 1. WEIGHT AND TORQUE MEASUREMENTS FOR DEVICES 1 TO 5

Torque Measurements (N-cm) Devices 1-5

Trial
No.

Weight
(lbs)*

Average
Torque

SD

1
2
3
4
5
6

3
8
13
18
23
28

1.14
4.95
8.48
11.30
14.13
16.95

1.14
4.24
5.68
8.48
9.89
12.72

1.14
4.24
7.06
8.48
12.72
15.54

1.14
4.24
5.65
8.48
15.54
16.95

1.14
2.83
5.65
9.18
11.30
13.42

1.14
4.10
6.50
9.18
12.72
15.12

0
0.77
1.26
1.22
2.23
1.97

*Weight increased in 5-lb increments starting with the weight of the apparatus, which was 3 lbs.

542

MANDIBULAR DISTRACTION FORCE

torque value for distraction is 4.24 N-cm (Table 2).

This torque value means that the force necessary to
move a distraction callus 0.5 mm during a regular rate
and rhythm of 0.5 mm twice per day is approximately
35.6 N. Brunner et al18 reported that the percentage
of muscle and soft tissue in the long bone that contributes to the total force measured is believed to be
very low. They also commented on studies by Aronson19 and Hollis,20 which found that in the sheep tibia
75% of the necessary distraction force was a result of
the callus itself and only 25% to the surrounding
tissue. It is conceivable that the force to distract is
proportional to the cross-sectional area of the callus,
modified by the rate, rhythm, and age of the patient.
The average force of 35.6 N needed to distract the
mandible means that in designing a device, greater
miniaturization is possible as long as a safety factor is
incorporated into the design. At times, it is necessary
to increase the distraction distance at each activation.
This increase approaches 8.48 N-cm for 0.75 mm of
lengthening (Table 2), which would place a requirement of 15 lbs on the device.
The current emphasis calls for greater miniaturization of the internal device.2,5,9,13,15,17 There is no standard regarding how much of a safety factor should be
engineered into the design. However, torque-force
measurements will help establish such standards
without compromising device integrity or safety. The
measurements of the forces at failure demonstrate
that the Bone Generator is capable of withstanding 6
times the required force to distract 0.5 mm. It would
seem that this margin is adequate to accommodate
most clinical problems. Building in a greater margin
requires larger designs and possibly greater manufacturing costs and is probably not necessary.
It is important to note that the data obtained from
the in vitro portion of this study measures only one of

FIGURE 5. Graph of torque versus force for the Bone Generator in the
in vitro portion of study. Torque was measured in Newton-centimeters
as a function of force in pounds. The heavy line shows the average of
the 5 tested devices. The slope and average torque values can be
used to determine the axial force encountered at the bone level when
various torque measurements are made during activation.

1.6 N-cm. The first 3 measurements for both the left

and right distraction devices in case number 3 were
not used in calculating the average because of skewed
data. It was discovered 7 days postoperatively that the
device on the right side had jammed secondary to an
incomplete osteotomy. The patient was returned to
the operating room to complete the osteotomy, and
the torque values then returned to expected levels.

Discussion
The torque force diagram shows that for the Bone
Generator, 7.06 N-cm of torque is equal to a force of
13 lbs. The in vivo data also show that the average
Table 2. TORQUE MEASUREMENTS FROM CLINICAL TRIALS

Measurement No.
1 (N-cm)

Measurement No.
2 (N-cm)

Measurement No. Measurement No. Measurement No. Measurement No.

3 (N-cm)
4 (N-cm)
5 (N-cm)
6 (N-cm)

Case

POD

POD

POD

15

20

3
4
5
6
7
8

Right

Left

17

5
9
14
6

2.83- 2.835.65 5.65

xx 2.835.65
9.89 1.41
2.08 4.24
4.24 4.24
2.83 2.83

14
13

1.41
2.83

xx
xx

Right

Left

Right

Left

POD

xx

12

Right

Left

POD

Right

Left

POD

Right

Left

2.83- 2.837.06 7.06

9.89

1.41

2.83

2.83

21

4.24

xx

7 14.13

2.83 7.06

14

4.24 5.65

16

2.83 5.65

Number of Turns*
11

2.83- 2.838.48* 8.48*

* Torque increased with each successive turn.

Abbreviations: POD, postoperative day; XX, unilateral case or no data obtained.

Right
Left

1st
2.83
2.83

2nd
4.24
4.24

3rd
8.48
8.48

N-cm
N-cm

543

ROBINSON, ONEAL, AND ROBINSON

the variables related to the force encountered in mandibular lengthening. The axial loads from the laboratory provide a great deal of information about the
force required to distract the callus. However, the in
vitro testing neglects to account for lateral forces,
such as forces from the suprahyoid muscles that are
frequently encountered during mandibular lengthening.13 The exact response and degree to which lateral
counteractive forces affect the bone callus will vary
with patient age, etiology,21 device rigidity,6,22,23 device orientation,24,25 and the vector of distraction.26-28
The effects of device orientation have yet to be established in the clinical setting and have thus far been
uneventful.29 Future studies, similar to the previously
mentioned studies by Brunner et al,18 Aronson,19 and
Hollis et al,20 will aim to establish the percentage of
force for the craniofacial model that is contributed by
the callus versus the surrounding muscle and connective tissue.
Device placement and the vector of distraction are
of paramount importance when planning craniofacial
distraction.25,30,31 This is of particular concern for
internal devices, which currently lack the ability for
bidirectional control. Even when multiplanar devices
are used, the planned distraction vector may differ
from the resultant vector because of forces encountered during and after elongation. The multidirectional device allows for a change in the distraction
vector. However, changing the vector of the distal
segment may induce a change in the position of the
proximal segment.26 Recent studies have demonstrated ways to prevent and augment a faulty distraction vector.26,32 Nonaxial forces will vary with
different vectors of elongation. Torque-force measurements from the clinical portion of this study dealt
primarily with vectors that were parallel and oblique
to the mandibular rami. No significant difference was
noted between torque readings with the varying vectors.
The ability to anticipate and quantify the force
encountered in mandibular distraction enhances the
development and design of devices. Torque-force
measurements will contribute to manufacturing standards and will help to establish an adequate margin of
safety. Calibrating craniofacial distraction devices
with torque-force measurements will also allow the
surgeon to monitor and exercise more control over
the distraction phase. For example, an incomplete
osteotomy may be detected and resolved at an earlier
stage. Premature consolidation may also be anticipated and possibly avoided. In addition, device failure
may be anticipated with excessive or minimal torque
measurements, leading to radiologic examination and
early detection. Case number 3 in the clinical trial
demonstrated 2 of the above situations (Table 2). The
progressive nature of the torque values for this case

prompted radiologic review and surgical exploration.

This patient maintained torque values on the right
side of the mandible of 9.89, 9.89, and 14.13 N-cm on
the fifth, sixth, and seventh day, postoperatively, respectively. These values were higher than expected
and considerably higher in comparison with the left
side, which only registered 1.41 N-cm. Surgical exploration confirmed an incomplete osteotomy causing
the right distraction device to jam.
Torque measurements are invaluable for monitoring the distraction phase from a perspective of safety
and control. Chin and Toth15 used torque measurements on patients who underwent a Le Fort III advancement to test and monitor the limits of fracture,
thus enabling rapid distraction. Chin and Toth used a
protocol that deviated from the standard by not observing a latency period and by performing 10 mm of
distraction intraoperatively followed by an additional
10 mm of distraction within 2 to 3 days following
surgery. Torque measurements of 14 to 18 N-cm were
observed without fracture. However, other complications are inherent with this technique.33 The protocol
for the current study maintained the standard rate and
rhythm of 0.5 mm twice a day, with a latency period
of 6 days. This rate and rhythm have permitted the
establishment of an average torque that falls within a
range of 1.5 to 7.0 N-cm. Clinical experience has
demonstrated that torque-force values that fall within
this range appear to be an acceptable measurement
during uneventful lengthening of the human mandible.
Measuring the force required to distract the human
mandible is difficult and is not currently reported in
the literature. The force of distraction has been measured in long bones, and this has helped to advance
the field of long bone distraction osteogenesis.22,34-38
Implications for future studies involving the force of
mandibular distraction will not only contribute to a
better understanding of mandibular distraction, but
will also offer the surgeon a valuable tool for monitoring the progression of the distraction phase.

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