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88:692-697, 2006. doi:10.2106/JBJS.E.00232 J. Bone Joint Surg. Am.
Salamipour
Timothy Bhattacharyya, Kimberly A. Bouchard, Anurada Phadke, James B. Meigs, Ara Kassarjian and Hamid

Nonunion
The Accuracy of Computed Tomography for the Diagnosis of Tibial
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The Accuracy of Computed

Tomography for the
Diagnosis of Tibial Nonunion
BY TIMOTHY BHATTACHARYYA, MD, KIMBERLY A. BOUCHARD, BA, ANURADA PHADKE, BA,
JAMES B. MEIGS, MD, ARA KASSARJIAN, MD, AND HAMID SALAMIPOUR, MD
Investigation performed at Partners Orthopaedic Trauma Service,
Massachusetts General Hospital and Brigham and Womens Hospital, Boston, Massachusetts
Background: When a patient is seen with a possible tibial nonunion and equivocal findings on plain radiographs, the
surgeon may choose to obtain a computed tomography scan to better delineate the bone anatomy. However, the sen-
sitivity and specificity of computed tomography in this setting is not known. We investigated the accuracy of com-
puted tomography for detecting nonunion in this clinical situation.
Methods: Thirty-five patients with equivocal findings on plain radiographs underwent computed tomography scan-
ning. The patients were first seen at an average of 9.7 months after the injury and had undergone a mean of 2.6 prior
operations. A so-called gold standard of union or nonunion was determined by either surgical findings (for twenty-five
patients who were operatively treated) or six months of clinical observation (for ten patients who had nonoperative
treatment). Computed tomography scans were assessed by two radiologists and one orthopaedic surgeon who were
blinded to the clinical outcome.
Results: Computed tomography scans displayed very good diagnostic accuracy. Intraobserver agreement was high
(intraclass correlation coefficient = 0.89), the sensitivity for detecting nonunion was 100%, and the overall accuracy
was 89.9%. Computed tomography was limited by a low specificity of 62%, as three patients who were diagnosed as
having tibial nonunion with computed tomography underwent surgery and were found to have a healed fracture.
Conclusions: Computed tomography displays very good accuracy in the evaluation of tibial fracture-healing. However, it
is limited by low specificity and may sometimes misrepresent a healed fracture as a nonunion. Surgeons must be aware
of this pitfall in order to accurately determine which patients need surgical intervention.
Level of Evidence: Diagnostic Level I. See Instructions to Authors for a complete description of levels of evidence.
ne of the most difficult diagnostic challenges in clini-
cal orthopaedics is the determination of whether a
fracture has healed. Ideally, symptoms of pain and a
lack of evidence of healing on radiographs would allow sur-
geons to detect all nonunions. However, plain radiographs
can often be difficult to interpret as overlying hardware ob-
scures the bone, and callus is not always visible. In addition,
pain is a poor discriminatora large number of patients, even
those with a healed fracture, have pain and dysfunction after
trauma
1-3
. The identification of a tibial nonunion is extremely
important because most patients with a nonunion require sur-
gery to achieve healing, while a delayed union heals without
intervention.
Computed tomography scanning offers a potentially more
accurate method to discriminate fracture union from non-
union. Despite its widespread use, to our knowledge, the diag-
nostic accuracy of computed tomography in the assessment of
bone-healing has never been evaluated. Without information
regarding the specificity and sensitivity of a diagnostic test, sur-
geons do not have adequate data to allow them to incorporate
the test into their clinical practice. We sought to determine the
diagnostic accuracy of computed tomography scanning in the
detection of tibial nonunion.
Materials and Methods
Study Population
he study was approved by our institutional review board.
The protocol at our institution is to obtain a computed
tomography scan of the tibia only if the plain radiographs and
clinical findings of fracture-healing are equivocal. All patients
O
T
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undergoing computed tomography scanning of the lower ex-
tremity over a three-year period were entered into a prospec-
tive database. We identified forty-eight patients who had a
computed tomography scan of the tibia performed specifically
for the assessment of fracture-healing (Fig. 1). The remaining
computed tomography scans of the tibia were done exclusively
on fresh intra-articular fractures for preoperative planning.
Thus, we were able to identify all patients who underwent com-
puted tomography scanning of the tibia, regardless of whether
they underwent surgery.
Three patients were excluded because they had been fol-
lowed for less than six months; four patients, because the scan
was performed to assess healing of an intra-articular ankle
fracture; and four patients, because no medical information
was available. Two patients were excluded because the scan
was obtained before three months had elapsed from the date
of the fracture (which was too early to rigorously classify the
fracture as a nonunion).
Thus, we identified thirty-five patients who had under-
gone computed tomography scanning for the assessment of a
possible tibial nonunion and had been followed clinically for a
minimum of six months. A review of the medical records con-
firmed that, for all thirty-five patients, the computed tomogra-
phy scan was obtained because the orthopaedic surgeon could
not determine union from nonunion on the basis of plain ra-
diographs and clinical examination.
Assessment with the Gold Standard
The medical records were reviewed to determine the final clin-
ical diagnosis for all thirty-five patients according to the so-
called gold standard (union at the time of surgery or after six
months of clinical observation). Twenty-five patients had as-
sessment of the degree of tibial fracture-healing (union or
nonunion) by direct inspection at the time of surgery. The re-
maining ten patients attended the orthopaedic clinic for a
minimum of six months without evidence of hardware com-
plication or breakage and clinically were considered to have
had fracture union.
Plain Radiography
Orthogonal radiographs of the tibia were made in a standard
fashion. They were reviewed by an orthopaedic traumatologist
who was blinded to the clinical data. The number of bridging
cortices was recorded, and an overall assessment of union was
made as well.
Computed Tomography Scanning Technique
The studies were performed on eight multidetector-row com-
puted tomography scanners. Seven scanners were made by
General Electric Medical Systems (Waukesha, Wisconsin), and
they ranged from four to sixteen detector-rows. One was a six-
Fig. 1
Flow chart of patients selected for the study.
TABLE I Characteristics of the Thirty-five Patients in the
Study Cohort
Mean age (range) (yr) 42 (19 to 70)
Mean time from injury to computed tomog-
raphy scan (range) (mo)
9.7 (3 to 29)
Mean no. of previous surgeries (range) 2.6 (0 to 8)
No. of patients who smoked 14 (40%)
Fracture location (no. of patients)
Metaphysis 19 (54%)
Diaphysis 16 (46%)
Fixation (no. of patients)
Plates/screws 18 (51%)
Nail 7 (20%)
External fixator 1 (3%)
Nail and plate 1 (3%)
None 8 (23%)
Final diagnosis (no. of patients)
Union 13 (37%)
Nonunion 22 (63%)
Method of final diagnosis (no. of patients)
Union
Surgical findings* 3 (9%)
Six months of observation 10 (29%)
Nonunion
Surgical findings 22 (63%)
*Bone found to be united at the time of surgery for treatment of
the nonunion.
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teen detector-row scanner built by Siemens Medical Solutions
(Forchheim, Germany). Detector configurations varied accord-
ing to the machines used and at the discretion of the supervis-
ing radiologist. Coronal and sagittal reformats were performed
for all thirty-five patients. The scans were obtained with use
of 2.5-mm slice thickness. Reconstruction intervals were per-
formed to a thickness of 1.25 mm.
Assessment of Computed Tomography Scans
Three reviewers (two musculoskeletal radiologists [A.K. and
H.S.] and one fellowship-trained orthopaedic trauma surgeon
[T.B.]) independently reviewed the computed tomography
scans. The reviewers were blinded to the clinical outcome and
to additional radiographic data, including previous radiographs
or computed tomography scans. The reviewers assessed the lo-
cation of the fracture, type of fixation, and number of bridging
cortices. To assess the number of bridging cortices, the axial cut
of the computed tomography scan was divided into quadrants.
The reviewers graded each scan as either fracture union or non-
union. In the case of disagreement, the majority opinion (two
of three reviewers) was taken as the proper assessment. Inter-
rater reliability was calculated with use of the intraclass correla-
tion coefficient two-way mixed model for consistency.
Statistical Methods
The data were analyzed with use of SPSS software (version 10.0;
SPSS, Chicago, Illinois). Sensitivity, the ability of computed to-
mography to detect nonunion of a fracture, was calculated by
dividing the total number of patients with a nonunion on com-
puted tomography scans by the total number of patients with a
true-positive nonunion (nonunion at the time of surgery).
Specificity, the ability of computed tomography to exclude non-
union, was calculated by dividing the number of patients with
union that was correctly diagnosed on computed tomography
scans by the number of patients with union according to the so-
called gold standard. Diagnostic accuracy was measured by the
kappa statistic, which measures the strength of agreement of the
findings on computed tomography with the gold-standard
assessment of union. A kappa value of >0.8 indicates almost
perfect agreement, while a kappa value of <0.4 indicates fair-to-
poor agreement.
We also calculated the area under the receiver operating
characteristic curve. The area under the receiver operating char-
acteristic curve represents the probability that computed tomog-
raphy scans correctly discriminate between patients with fracture
union and those with nonunion, where 0.5 is chance discrimi-
nation and 1.0 is perfect discrimination.
Results
he final study cohort consisted of twenty-two patients with
nonunion and thirteen patients with union. The charac-
teristics of the study cohort are shown in Table I. The mean
time from the injury to the computed tomography scan was
T
TABLE II Accuracy of Plain Radiography for the Detection
of Nonunion*
Clinical Gold
Standard
(no. of patients)
Total Union Nonunion
Plain radiography (no. of patients)
Union 8 10 18
Nonunion 5 12 17
Total 13 22 35
*The sensitivity for detecting nonunion is 54%, and the specific-
ity is 62% (kappa = 0.14, p = 0.36).
TABLE III Accuracy of Computed Tomography for the
Detection of Nonunion*
Clinical Gold
Standard
(no. of patients)
Total Union Nonunion
Computed tomography scan (no.
of patients)
Union 8 8
Nonunion 5 22 27
Total 13 22 35
*The sensitivity for detecting nonunion is 100%, and the speci-
ficity is 62% (kappa = 0.668, p < 0.0001).
TABLE IV Summary of Findings in the Evaluation of Tibial Fracture-Healing
Clinical Gold Standard Plain Radiography Computed Tomography No. of Patients
Union Union Union 5
Union Union Nonunion 3
Union Nonunion Union 3
Union Nonunion Nonunion 2
Nonunion Nonunion Nonunion 12
Nonunion Union Nonunion 10
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9.7 months (range, three to twenty-nine months). The mean
number of surgeries on the tibia prior to computed
tomography examination was 2.6 procedures (range, zero to
eight procedures). Twenty-seven patients (77%) had hardware
in place at the time of computed tomography scanning.
Table II summarizes the accuracy of plain radiography
in the detection of nonunion. As expected in this difficult
group of fractures, plain radiography led to the incorrect clas-
sification of fifteen fractures (43%). The kappa statistic for
plain radiography compared with the so-called gold standard
was 0.14, indicating poor diagnostic accuracy.
In contrast, computed tomography scanning had very
good accuracy in the detection of nonunion in this complex
group of fractures (Table III). Computed tomography scanning
was 100% sensitive for nonunion. The kappa statistic for com-
puted tomography scanning compared with the gold standard
was 0.67, indicating good diagnostic accuracy. The intraclass
correlation coefficient was 0.89, indicating almost complete
agreement among the three observers about the diagnosis.
Figure 2 depicts the receiver operating characteristic curve
for computed tomography scanning in the detection of non-
union. The area under the receiver operating characteristic curve
was 89.9%. This indicates that computed tomography accurately
discriminated between subjects with fracture union and those
with nonunion. A clinical example of the sensitivity of computed
tomography scanning is shown in Figure 3.
Computed tomography scanning, however, displayed a
limited specificity of only 62%. For five patients, the diagnosis
of nonunion was made on the basis of computed tomography
scans but the patients were found to have union. For two pa-
tients, the surgeons ignored the findings on the computed to-
mography scans and the fractures were later determined to be
healed clinically. Three of the five patients actually underwent
surgery with the intent to treat the nonunion, and the surgeon
found that the fracture had united (Fig. 4). None of these three
patients required further surgery.
A summary showing the agreement among the findings
on plain radiography, computed tomography scanning, and
the clinical gold standard is shown in Table IV.
Discussion
n this study of patients with a possible tibial nonunion and
equivocal findings on radiographs, computed tomography
scanning demonstrated a very good diagnostic accuracy. How-
ever, computed tomography scanning had limited specificity
I
Fig. 2
Receiver operating characteristic (ROC) curve of computed tomography
scanning for the detection of nonunion. A larger area under the curve
indicates a better ability to discriminate union from nonunion. The diag-
onal line represents equal probability.
Fig. 3
A twenty-two-year-old man was referred for evaluation of a painful tibial
fracture six months after open reduction and internal fixation. Plain ra-
diographs show good bone apposition and apparent union (A and B).
Computed tomography scans with coronal (C) and sagittal reformats (D)
reveal a nonunion with the fracture line still evident. The patient was
found to have a nonunion at the time of surgical exploration.
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and tended to lead to a diagnosis of nonunion when, indeed,
the fracture was healed in some patients.
There are very limited data in the literature on diagnos-
tic tests to evaluate tibial fracture-healing or fracture-healing
in general. Traditionally, the combination of pain and lack of
healing on successive radiographs is coupled with clinical
judgment to lead to the diagnosis of a nonunion
4
. Unfortu-
nately, a number of patients with a healed tibial shaft fracture
continue to have pain three years after the injury, making pain
a poor discriminator of union from nonunion
1
. Hammer et
al., in a study of 208 patients, showed that plain radiography
was no more accurate than a coin flip in determining tibial di-
aphyseal fracture union
5
. Bhandari et al. surveyed 444 practic-
ing orthopaedic surgeons and found a wide variation in the
criteria used to diagnose nonunion
6
. Thus, better tests and
criteria are needed. To the best of our knowledge, the present
study is the first to rigorously analyze a clinically available di-
agnostic test for nonunion.
A principal question in any study of diagnostic accuracy
is the generalizability of the results. By starting with a database
of all patients who underwent computed tomography scanning
in our institution, we were able to identify patients with a possi-
ble nonunion, whether they were treated operatively or nonop-
eratively. We used computed tomography to selectively evaluate
the fractures that had equivocal findings on plain radiographs
with regard to union. A review of the medical records con-
firmed that equivocal radiographic findings and concern for
nonunion were the indications for computed tomography. This
is precisely the group of patients for whom most orthopaedic
surgeons would use computed tomography scanning.
Fig. 4
A fifty-five-year-old woman was referred for evaluation of a painful extremity after three previous surger-
ies. The plain radiographs are difficult to interpret (A and B). The computed tomography scans were
read as a tibial nonunion (C and D). The patient underwent surgical exploration and was found to have a
united fracture.
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In an attempt to clarify the clinical role of computed to-
mography scanning in the assessment of tibial fracture-healing,
we performed the first study of which we are aware that com-
pares the diagnostic test with a so-called gold standard. Previous
studies have noted that computed tomography can detect non-
union, but they did not fully integrate the test into the clinical
picture
7,8
. We found computed tomography scanning to be a re-
liable test with high interobserver agreement. The intraclass cor-
relation coefficient was 0.89, indicating that different observers
would be highly likely to interpret the scans in a similar fashion.
The computed tomography scan was also highly sensitive as it
detected all of the patients who had a true nonunion, as con-
firmed by intraoperative assessment. Computed tomography
scanning also accurately discriminated union from nonunion,
as evidenced by the large area under the receiver operating char-
acteristic curve. Finally, we found that computed tomography
scanning accurately delineated the osseous architecture even
though the majority of patients had hardware in place.
The main drawback to the computed tomography scan
in the assessment of tibial fracture-healing is its somewhat low
specificity. Because the treatment of nonunion is often surgi-
cal, surgeons need a test with high specificity as they would
like to avoid taking a patient to the operating room only to
find a healed tibial fracture. (This approach is in contrast to
cancer screening, where high sensitivity is required to detect
all tumors.) Evaluation with computed tomography led to the
incorrect classification of nonunion in three patients, who
proved to have a healed fracture on operative inspection. Two
additional patients were classified with computed tomography
scanning as having nonunion, but the surgeons chose to fol-
low the patients and the fractures healed uneventfully. The
computed tomography scan delineates the osseous architec-
ture to a very fine degree, and it can occasionally depict clefts
in bone that are of uncertain clinical importance. Understand-
ing this limitation to computed tomography scanning may
prevent surgeons from embarking on unnecessary surgery.
Our study has a few limitations. The computed tomogra-
phy scans were reviewed in a relative information vacuum for
the purposes of study rigor; most radiologists and surgeons
would review the computed tomography scan in conjunction
with the previous plain radiographs and other clinical data. The
study is retrospective in nature and is subject to recall bias. We
did not perform an intrarater reliability study because the reli-
ability of computed tomography scanning was established by
Grigoryan et al.
9
. The study cohort is small. However, we believe
that most nonunions can be diagnosed on the basis of plain ra-
diographs, history, and clinical examination alone; thus, the
population of patients with equivocal nonunion is small.
In summary, we present information regarding the eval-
uation of tibial fracture-healing with use of computed tomog-
raphy scans that orthopaedic surgeons can incorporate into
their clinical practice. The computed tomography scan is ex-
tremely sensitive for detecting tibial nonunion. However, it
has limited specificity, and surgeons must couple computed
tomography and clinical findings to minimize the risk of mak-
ing a false-positive diagnosis of nonunion.
Timothy Bhattacharyya, MD
Kimberly A. Bouchard, BA
Anurada Phadke, BA
Partners Orthopaedic Trauma Service, Massachusetts General Hospital,
55 Fruit Street, Yawkey 3600, Boston, MA 02118.
James B. Meigs, MD
General Medicine Division, Massachusetts General Hospital, 50 Stani-
ford Street, 9th Floor, Boston, MA 02114
Ara Kassarjian, MD
Hamid Salamipour, MD
Department of Radiology, Division of Musculoskeletal Radiology,
Massachusetts General Hospital, 55 Fruit Street, Yawkey 6th Floor,
Room 6040, Boston, MA 02114
The authors did not receive grants or outside funding in support of their
research for or preparation of this manuscript. They did not receive pay-
ments or other benefits or a commitment or agreement to provide such
benefits from a commercial entity. No commercial entity paid or di-
rected, or agreed to pay or direct, any benefits to any research fund,
foundation, educational institution, or other charitable or nonprofit
organization with which the authors are affiliated or associated.
doi:10.2106/JBJS.E.00232
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