ORIGINAL ARTICLE
Nonoperative Treatment of the Medial Malleolus in
Bimalleolar and Trimalleolar Ankle Fractures: A Randomized
Controlled Trial
Sigurd Erik Hoelsbrekken, MD, PhD, Kjersti Kaul-Jensen, MD, Thale Mrch, MD, Hvard Vika, MD,
Torkil Clementsen, MD, yvind Paulsrud, MD, Gunnar Petursson, MD, Morten Stiris, MD,
and Knut Strmse, MD, PhD
Objectives: To compare internal xation with no xation of the
medial malleolus after open reduction and internal xation of the
lateral malleolus and if needed, the posterior malleolus.
Design: Randomized prospective trial.
Setting: Level III trauma center in a metropolitan area.
Patients: One hundred patients with bimalleolar or trimalleolar
Orthopaedic Trauma Association type 44 ankle fractures and
displacement of the medial malleolus less than 2 mm after open
reduction and internal xation of the lateral component.
Intervention: Internal xation or nonoperative treatment of the
medial malleolus.
Main Outcome Measurements: American Orthopaedic Foot
and Ankle Society ankle hind foot score (AOFAS), The Olerud
Molander Ankle (OMA) score, and visual analogue pain scale (VAS).
Results: Median follow-up time was 39 months (range: 2472).
There were no signicant differences between the 2 groups with
respect to OMA (P = 0.91), AOFAS (P = 0.85), VAS (P = 0.85),
or development of osteoarthritis (P = 0.22). Reoperation and com-
plication rates were also comparable, but 4 patients treated nonop-
eratively developed nonunion of the medial malleolus. These
patients reported no functional disabilities and presented OMA,
AOFAS, and VAS scores better than average.
Conclusions: Our data indicate that nonoperative treatment
of minimally displaced fractures of the medial malleolus after
operative xation of the bula yields satisfactory results. However,
long-term follow-up is needed due to increased risk of nonunion and
uncertainty regarding the development of posttraumatic arthritis.
Accepted for publication February 7, 2013.
From the Department of Orthopedic Surgery, Oslo University Hospital, Aker,
Norway.
The authors report no funding or conicts of interest.
The authors S. E. Hoelsbrekken and K. K. Jensen contributed equally to the
work.
The Regional Ethics Committee for Medical Research has approved the
present study (REK Helseregion st, approval number 224-01077).
Reprints: Sigurd Erik Hoelsbrekken, MD, PhD, Department of Orthopedic
Surgery, Akershus University Hospital, 1478 Lrenskog, Norway (e-mail:
s.e.hoelsbrekken@medisin.uio.no).
Copyright 2013 by Lippincott Williams & Wilkins
J Orthop Trauma  Volume 27, Number 11, November 2013
Key Words: internal xation, ankle fracture, medial malleolus
Level of Evidence: Therapeutic Level II. See Instructions for
Authors for a complete description of levels of evidence.
(J Orthop Trauma 2013;27:633637)
INTRODUCTION
Ankle fractures represent one of the most common
injuries treated by orthopedic surgeons, and open reduction
and internal xation (ORIF) is generally recommended for the
treatment of displaced and unstable fractures.
The stability of the ankle joint relies on the following
structures: the lateral complex consisting of the lateral
malleolus and the lateral ligaments; the medial complex
consisting of the medial malleolus and the deltoid ligaments;
and the anterior and posterior syndesmotic ligaments. Dening
stability as the ability of the ankle to withstand physiological
stress without displacement, the injured ankle maintains its
stability as long as 3 of these structures remain intact.1 Rup-
tures of the ligaments are occasionally seen in association with
osseus injuries,2,3 but usually a fracture of the lateral or medial
malleolus indicates competence of the ligaments.
The Scottish surgeon Arbuthnot Lane pioneered the
operative treatment of ankle fractures. He emphasized perfect
anatomical reconstruction to prevent the development of
posttraumatic arthritis. Lane also maintained that the length
and the alignment of the bula had to be restored to
reestablish congruence in the mortise.4 These ideas were chal-
lenged by Muller,5 and until the 1960s, it was commonly
believed that the medial malleolus represented the key ele-
ment in achieving anatomical reduction and joint congruence.
Later the works of Tauber et al, Willenegger et al6,7 and
Yablon et al8 reemphasized the signicance of the lateral
malleolus. They also showed that consistent anatomical
reduction relied on initial reduction of the lateral compo-
nent.810
During a 2-year period (19992000), 15 patients sustain-
ing displaced or unstable bimalleolar or trimalleolar ankle frac-
tures were treated surgically at our clinic with ORIF of the
lateral malleolus alone due to medial soft tissue injuries. A
retrospective survey revealed that 13 of these 15 patients pre-
sented functional results comparable to patients treated with
ORIF of both malleoli. We also observed that the medial
www.jorthotrauma.com | 633
Hoelsbrekken et al
malleolus tended to realign after ORIF of the lateral compo-
nent.11 Based on these ndings, we hypothesized whether it is
necessary to treat a nondisplaced medial malleolar fracture
with internal xation after adequate ORIF of the lateral
component.
To address this question, we developed a prospective
randomized trial comparing internal xation with no xation
of the medial component. To our knowledge, this question has
not been addressed in previous reports, although Herscovici
et al12 achieved high rates of union and good functional results
after conservative treatment of isolated fractures of the medial
malleolus. Our study included both bimalleolar and trimalleo-
lar ankle fractures and the purpose was to determine if medial
malleolar fractures displaced less than 2-mm [anteroposterior
(AP) view with 20-degree angle of internal rotation] required
xation after ORIF of the lateral component.
PATIENTS AND METHODS
Patient Population
The present study was approved by the Regional Ethics
Committee for Medical Research (REK Helseregion st, ap-
proval number 224-01077) and registered with ClinicalTrials.
gov (NCT01441817). Written informed consent was obtained
from each patient. Patients older than 18 years of age with
Orthopaedic Trauma Association (OTA/AO)13 type 44 fractures
(B2, B3, C2 and C3) referred to our clinic during the time period
May 2002 to February 2006 were considered for participation.
Exclusion criteria included patients with OTA/AO type 43 distal
tibia fractures, patients with soft tissue injuries involving the
medial malleolus and patients with open or pathological
fractures. Age, gender, body mass index (BMI), comorbidity
and American Society of Anesthesiologists (ASA) class were
registered preoperatively. Obesity (BMI $30) was dened
according to the World Health Organization classication.14
Operative Procedure
Patients were submitted to surgery within 9 days of
their injury, and all surgeons on call participated in the study.
Open reduction and internal xation of the lateral malleolus
was performed according to the AO recommendations using
AO implants and techniques,15 and ORIF of the posterior
fragment was conducted if the fragment involved more than
25% of the articular surface. Syndesmotic instability with
respect to OTA/AO type 44-B fractures was then evaluated
by the hook test.16 The test was performed by stabilizing tibia
with one hand and concomitantly applying a lateral force to
the lateral malleolus using a bone hook. If more than 2 mm of
lateral movement was observed under direct vision, the test
was considered positive and transxation performed using
one 4.5 mm quadricortical screw or two 3.5-mm tricortical
screws. Finally, the position of the medial malleolus was
assessed by an AP uoroscopic view with the foot in 20-
degree angle of internal rotation, allowing visualization of
both the lateral and medial joint spaces. If displaced less than
2 mm, the patient was eligible for inclusion and randomized
to either internal xation or nonoperative treatment of the
medial malleolus. Fixation was usually performed using
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J Orthop Trauma  Volume 27, Number 11, November 2013
two 3.5-mm lag screws. However, 2 of the patients were
treated with either tension band osteosynthesis using cerclage
and 2 K-wires or the combination of a single K-wire and one
3.5-mm lag screw due to small medial fragments. A short leg
cast was applied after surgery, and the patients were restricted
to bed rest with the limb elevated for 72 hours. Subsequently
the cast was removed, and the patients allowed partial weight
bearing the next 6 weeks. All patients were given low molec-
ular heparin until adequately mobilized.
Method of Randomization
A computer program generated allocation codes using
random permuted blocks. The allocation codes were then
placed in sealed opaque envelopes administered by the nursing
staff and opened in the operating theater after uoroscopic
assessment of the position of the medial malleolus.
Follow-Up and Outcome
The wound was inspected and sutures removed after 2
weeks, and patients were examined clinically and radiograph-
ically after 6 weeks. Patients later returned for a follow-up
examination, and 3 observers assessed long-term results.
None of these observers were blinded to treatment alloca-
tions. The lack of a standardized end point was due to
logistical challenges imposed by an unforeseen long inclusion
period. The Olerud Molander Ankle (OMA) score 17 and the
American Orthopaedic Foot and Ankle Society ankle hind
foot score (AOFAS)18 were used to describe functional out-
come. The OMA score is a self-administered patient question-
naire based on the following 9 items: pain, stiffness, swelling,
stair climbing, running, jumping, squatting, supports, and
activities of daily living. It is frequently used to evaluate
subjectively scored function after ankle fractures.17,1921 The
AOFAS score includes 3 subcategories for pain, function, and
alignment.22 Pain was also measured by the use of a visual
analog scale23 (with the end points 10 representing absence of
pain and 0 representing severe pain). The same radiologist
examined all x-rays and presence of posttraumatic osteoar-
thritis (OA) was evaluated according to the criteria of Mag-
nusson (stage I-IV),24 the radiologist performing these
examinations was blinded to the main hypothesis. Stage I
OA is characterized by narrowing of the talocrural joint less
than 50% compared to the contralateral side. Stage II implies
more than 50% narrowing whereas stage III is dened by
bone on bone contact. Stage IV involves bone destruction.
OA classications were based on weight-bearing x-rays (AP
view with 20-degree angle of internal rotation). A radio-
graphic persistent radiolucent fracture line dened nonunion.
Sample Size and Statistical Methods
The sample size calculation was based on detecting
a difference of 10 points with regard to the outcome measures
OMA score and AOFAS assuming a SD of 15. It has
previously been shown that a difference of 14 points represents
clinical signicance with regard to the OMA score, and that
patients with radiological signs of posttraumatic arthritis score
on average 11 points lower compared with patients without
any signs.17 To obtain statistical power of 80% with a P value
less than 0.05, 37 patients were needed in each group. To
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J Orthop Trauma  Volume 27, Number 11, November 2013 Nonoperative Treatment of the Medial Malleolus in Bimalleolar and
Trimalleolar Ankle Fractures

allow for loss during follow-up, a total of 100 patients were

TABLE 2. Details of Complications in Both Groups
included in the study. Statistical analysis was performed using
PASW 18 (IBM Corporation, Somers, NY). Differences in Internal Fixation
of Medial No Fixation
outcome with regard to categorical variables such as osteoar- Malleolus (n = 37) (n = 45) P
thritis were assessed by Pearson x2 test, and means were com-
Infection (%)
pared by independent samples t test. Regression analyses were
Total 2 (5) 4 (9) 0.55
performed to adjust for the effects of ASA scores and BMI.
Deep 0 2 (4) 0.19
The signicance level was set to 0.05.
Supercial 2 (5) 2 (4) 0.84
Nonunion (%) 0 4 (9) 0.063
Malposition (%) 4 (11) 3 (7) 0.15
RESULT Arthrosis (%) 3 (8) 1 (2) 0.22
Deep venous thrombosis 1 (3) 0 (0) 0.45
Group Compositions and Complication Rates
One hundred and sixty-three patients were considered
for inclusion, 26 failed to meet the inclusion criteria, and 1
patient declined to participate. Of the 100 patients random- Functional Results
ized to either internal xation or nonoperative treatment of the Mean (median, range) follow up time for operative
medial malleolus, 18 were lost to follow-up. The remaining treatment was 44 months (37, 2472) and for non-operative
37 patients treated with xation and 45 patients receiving no treatment 41 months (41, 2467). There were no signicant
xation were included for nal analysis. Mean age and gender differences between the 2 groups with regard to OMA and
were similar between the 2 groups. The groups were also AOFAS scores, and the results were good in each group. The
comparable with regard to OTA/AO classication, BMI, ASA a priori stated clinical signicance of a 10 points difference in
score, and diabetes, although the group treated with internal OMA score was higher than the 95% condence interval of
xation of the medial malleolus had a higher percentage of the mean difference, rendering type II error due to a small
patients with obesity and ASA score III (Table 1). The mean sample size more unlikely (Table 3). Furthermore, we found
duration of surgery was signicantly longer in the group no difference in reported pain evaluated by the visual ana-
treated with xation compared with the no xation group logue scale (VAS) score (Table 3). Due to differences of
(102 minutes vs. 75 minutes, P , 0.01) (Table 1), but the group compositions, regression analyses adjusting for BMI
numbers of postoperative infections were comparable and ASA scores were performed, but the resulting P values
(Table 2). Although all diagnosed infections were culture remained nonsignicant with regard to OMA, AOFAS, and
positive, only deep subfascial infections required revision VAS scores (data not shown). Overall, patients sustaining
surgery. Deep venous thrombosis occurred in only 1 case OTA/AO type C3 fractures fared better compared with other
(Table 2). In the no-xation group, 3 patients required addi- fracture types, although the differences were only signicant
tional surgery due to complications. Two of these patients with regard to the OMA score and the number of patients few.
were treated for infections and 1 patient developed Charcot We observed poorer outcome in diabetic and obese patients in
arthropathy. In the xation group, a single patient required consistency with previous reports25,26 (Table 4), although the
repeated surgery due to malposition of the screws on the inuence of obesity has been debated.27
medial side.
Anatomical Results
None of the patients in the internal xation group
TABLE 1. Demographics and Fracture Classification developed nonunion of the medial malleolus compared with
Internal Fixation 4 patients treated with no xation (Table 2). Nonunion was
of Medial No Fixation veried by x-ray examination alone, and the patients reported
Malleolus (n = 37) (n = 45) no functional disabilities and registered OMA, AOFAS,
Male: female ratio 15:22 16:29 and VAS scores above average (Table 4). None required
Mean age (SD) 49 (17) 56 (14)
Patients with diabetes (%) 6 (16) 6 (13)
Obesity (BMI $30) (%) 9 (26) 8 (18)
ASA score (%) TABLE 3. Functional Results
I 7 (19) 11 (24) Internal Fixation No Mean
II 23 (62) 29 (64) of Medial xation difference
Malleolus (n = 37) (n = 45) (95% CI) P
III 7 (19) 5 (11)
OTA/AO fracture type (%) OMA 80 (20) 81 (23) 0.9 (28.5 to 10) 0.91
B2 16 (43) 20 (44) AOFAS 88 (13) 87 (18) 20.4 (27.4 to 6.6) 0.85
B3 14 (38) 17 (38) VAS 7.6 (2.1) 7.7 (2.3) 0.9 (28.6 to 10) 0.87
C2 6 (16) 6 (13) The values are given as mean and standard deviation. OMA, Olerud and Molander
C3 1(3) 2 (4) outcome score; AOFAS, Ankle-hindfoot scale of the American Orthopaedic Foot and
Ankle Society; VAS, visual analogue scale.
Syndesmosis xation (%) 24 (65) 27 (60)

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Hoelsbrekken et al J Orthop Trauma  Volume 27, Number 11, November 2013

a decreased contact area between the tibia and talus.28,29 To

TABLE 4. Results Dependent on Fracture Type, Obesity,
our knowledge, displacement of the medial malleolus does not
Diabetes, Nonunion, and Malposition
share a similar biomechanical signicance as long as the lat-
n OMA AOFAS VAS eral malleolus remains intact. However, this may be inuenced
Total population 82 81 87 7.7 by the extent of the medial fracture, and we did not distinguish
OTA/AO fracture type between different medial avulsions apart from the exclusion of
B2 36 79 87 7.5 vertical shear fractures representing OTA/AO type 44-A frac-
B3 31 83 88 7.8 tures. Furthermore, it is important to emphasize that progres-
C2 12 79 84 7.5 sion of secondary osteoarthritis cannot be excluded as
C3 3 95* 99 9.5 posttraumatic arthritis may take several decades to develop.30
Obesity (BMI $30) 17 73* 82* 6.9 The present study has certain limitations that need to be
Diabetes 12 74* 80* 7.8 taken into account when drawing any conclusions. A notable
Nonunion medial malleolus 4 93* 95 8.7 weakness is the lack of preinjury AOFAS, OMA, and VAS
Malposition medial malleolus 7 74 81 7.9 scores from which to compare treatment results, although the
*P , 0.05. operative and nonoperative treatment groups seemed similar
in their compositions (Table 1). Furthermore, the end point
was not standardized, and we do not know if initial or later
differences in treatment results were masked by differing end
additional surgery. Four patients treated with internal xation points. Other weaknesses were the number of patients lost to
ended up with the medial malleolus healing in malposition follow-up, which is in the upper limit of what is generally
compared with 3 patients in the nonoperative group (Table 2). considered acceptable, and the inclusion of different fracture
Collectively, these patients tended to present AOFAS and patterns such as OTA/AO type 44-B and 44-C irrespective of
OMA scores below average, but the differences were not injuries to the syndesmosis. The latter make comparisons less
signicant (Table 4). We observed no signicant differences clear-cut, even though the different fracture types and the
with regard to development of posttraumatic osteoarthritis number of syndesmosis injuries were evenly distributed
between the groups, and a total of 4 patients, of which 3 were between the 2 treatment groups.
randomized to operative treatment, displayed signs of osteo- The advantages of nonoperative treatment of the medial
arthritis veried by x-rays according to the criteria of Mag- component are shorter duration of surgery and avoidance of
nusson (Table 2). potential risks such as malposition of the osteosynthesis
device and implant-related infections on the medial side.
However, it is important to emphasize that the risk of these
DISCUSSION complications is low and surgery can be carried out with
Our data indicates that xation of the lateral malleolus relative ease. We did not observe any medial infections in our
alone carries acceptable results when the medial malleolus is material, but 1 patient required additional surgery due to
spontaneously reduced upon anatomical reduction and internal malposition of the lag screws. Overall, our ndings do
xation of the lateral malleolus, and follow-up shows that indicate that sole xation of the lateral malleolus is a possible
functional results are comparable to patients treated with ORIF treatment option, but given the uncertainty related to pro-
of both malleoli. A potential disadvantage is the relatively gression of posttraumatic arthritis, nonoperative treatment of
high incidence of nonunion after nonoperative treatment of the the medial malleolus has to be restricted to situations where
medial malleolus. Although patients developing nonunion medial soft tissue injuries does not permit surgery. Non-
presented results similar to patients with uncomplicated operative treatment of the medial malleolus also resulted in
fracture healing, the data has to be interpreted with caution. a higher rate of nonunion, and although nonunion did not
In a larger sample population, nonunion of the medial seem to worsen the functional outcome, the nding is of
malleolus may result in a poorer functional outcome. The uncertain clinical signicance. This underlines the need for
medial complex being secondary to the lateral malleolus in long-term follow-up, especially regarding the risk of devel-
providing realignment of the mortise8,9 may explain the appar- oping posttraumatic arthritis.
ent lack of symptoms. It is also important to emphasize that
nonunion was determined by x-ray examination alone. Three
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