Fracturas Melolares

Original Investigation | Orthopedics
Operative vs Nonoperative Management of Unstable Medial Malleolus Fractures

A Randomized Clinical Trial
Thomas H. Carter, MD; William M. Oliver, LLB, (Hons), MD; Katrina R. Bell, MBChB, (Hons); Catriona Graham, MSc;
Andrew D. Duckworth, MSc, PhD; Timothy O. White, MD
Abstract Key Points

Question Is internal fixation of well-
IMPORTANCE Unstable ankle fractures are routinely managed operatively. However, because of
reduced, medial malleolus fractures
soft tissue and implant-related complications, recent literature has reported on the nonoperative
superior to nonfixation after fibular
management of well-reduced medial malleolus fractures after fibular stabilization, but with limited
stabilization when treating unstable
evidence supporting the routine application.
ankle injuries?
OBJECTIVE To assess the superiority of internal fixation of well-reduced (displacement ⱕ2 mm) Findings This randomized clinical trial
medial malleolus fractures compared with nonfixation after fibular stabilization. of 154 patients found no significant
difference 1 year postoperatively
DESIGN, SETTING, AND PARTICIPANTS This superiority, pragmatic, parallel, prospective between fixation and nonfixation with
randomized clinical trial was conducted from October 1, 2017, to August 31, 2021. A total of 154 adult respect to patient-reported outcomes
participants (ⱖ16 years) with a closed, unstable bimalleolar or trimalleolar ankle fracture requiring and complications. However, 1 in 5
surgery at an academic major trauma center in the UK were assessed. Exclusion criteria included patients developed a radiographic
injuries with no medial-sided fracture, open fractures, neurovascular injury, and the inability to nonunion after nonfixation, although
comply with follow-up. Data analysis was performed in July 2022 and confirmed in September 2023. the reintervention rate to manage
symptoms was low.
INTERVENTIONS Once the lateral (and where appropriate, posterior) malleolus had been fixed and
Meaning These findings suggest that
satisfactory intraoperative reduction of the medial malleolus fracture was confirmed by the
nonfixation of well-reduced medial
operating surgeon, participants were randomly allocated to fixation (n = 78) or nonfixation (n = 76)
malleolar fractures after fibular
of the medial malleolus.
stabilization is a valid treatment option
for unstable ankle fractures, particularly
MAIN OUTCOME AND MEASURE Olerud-Molander Ankle Score (OMAS) 1 year after randomization
if the fracture is anatomically reduced.
(range, 0-100 points, with 0 indicating worst possible outcome and 100 indicating best
possible outcome).
+ Visual Abstract
RESULTS Among 154 randomized participants (mean [SD] age, 56.5 [16.7] years; 119 [77%] female),
144 (94%) completed the trial. At 1 year, the median OMAS was 80.0 (IQR, 60.0-90.0) in the fixation
+ Supplemental content
Author affiliations and article information are
group compared with 72.5 (IQR, 55.0-90.0) in the nonfixation group (P = .17). Complication rates
listed at the end of this article.
were comparable. Significantly more patients in the nonfixation group developed a radiographic
nonunion (20% vs 0%; P < .001), with 8 of 13 clinically asymptomatic; 1 patient required surgical
reintervention for this. Fracture type and reduction quality appeared to influence fracture union and
patient outcome.
CONCLUSIONS AND RELEVANCE In this randomized clinical trial comparing internal fixation of
well-reduced medial malleolus fractures with nonfixation, after fibular stabilization, fixation was not
superior according to the primary outcome. However, 1 in 5 patients developed a radiographic
nonunion after nonfixation, and although the reintervention rate to manage this was low, the future
implications are unknown. These results support selective nonfixation of anatomically reduced
medial malleolar fractures after fibular stabilization.
(continued)
Open Access. This is an open access article distributed under the terms of the CC-BY License.
JAMA Network Open. 2024;7(1):e2351308. doi:10.1001/jamanetworkopen.2023.51308 (Reprinted) January 18, 2024 1/13
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JAMA Network Open | Orthopedics Operative vs Nonoperative Management of Unstable Medial Malleolus Fractures
Abstract (continued)
TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03362229
JAMA Network Open. 2024;7(1):e2351308. doi:10.1001/jamanetworkopen.2023.51308
Introduction
Ankle fractures comprise approximately 10% of all fractures,1 with an annual incidence of 122 to 184
per 100 000 person-years (1:800).2 Conventionally, the medial malleolar component of unstable
fractures has been treated through open reduction and internal fixation.3 Screw fixation is
recommended for most, although debate continues regarding screw type, length, number, and zone
of insertion.4-8 For fractures unsuitable for screw fixation, tension band wiring is recommended.9-11
High rates of symptomatic implant(s) after these techniques have driven the development of
headless screws, knotless systems, and bioresorbable implants, with encouraging results.12-19
Previous studies have demonstrated excellent patient-reported outcomes and union rates as
high as 96% in patients with isolated stable medial fractures treated conservatively.20,21 For unstable
ankle fractures, after operative stabilization of the fibula, if the medial malleolus is well reduced,
some authors have applied a similar principle of nonoperative management, reporting equivalent
functional outcome when compared with fixation.22-24 This principle is based on the anatomical
arrangement of the osteoligamentous complex25 and that consequently medial fracture fixation may
not increase ankle joint stability.24,26 The only randomized clinical trial to date reported no
statistically significant difference in functional outcome between the 2 groups at a mean follow-up of
44 months in 82 patients,23 with a nonoperative radiographic nonunion rate of 8%. However, this
study was limited by a lack of baseline outcome data and a small sample size. The aim of the Medial
Malleolus: Operative or Nonoperative (MOON) trial was to test the hypothesis that internal fixation
of well-reduced medial malleolus fractures is superior to nonfixation after operative fibular
stabilization in adult patients undergoing surgical management.
Methods
This superiority-design, pragmatic (ie, under routine clinical practice conditions), prospective,
parallel randomized clinical trial followed the Consolidated Standards of Reporting Trials (CONSORT)
reporting guidelines.27 It was conducted at an academic major trauma center in the UK between
October 1, 2017, and August 31, 2021, that delivers orthopedic care to a population of approximately
850 000. Data on race and ethnicity were not collected because these data were not planned for in
our protocol or analysis. All participants provided informed consent. Ethical approval was granted by
the South-East Scotland Research Ethics Service 2. The trial protocol has been previously published
and can be found in Supplement 1.28
Participants
Adult patients (aged ⱖ16 years) presenting within 2 weeks of injury with an unstable bimalleolar or
trimalleolar ankle fracture were considered. Patients were excluded if they did not have a fracture of
the medial malleolus, were unable to give consent or comply with follow-up, had an open fracture,
had an associated neurovascular injury, or had a significant associated lower limb injury that would
affect rehabilitation. Patients with isolated medial malleolus and vertical shear fractures were
excluded (Figure 1). Because of the health care impact of the SARS-CoV-2 pandemic, recruitment was
suspended between February 1, 2022, and June 15, 2022. During this time, 31 potential participants
were missed.

Randomization
Randomization was allocated on a 1:1 ratio and stratified by age (<65 years and ⱖ65 years, which was
factored into the computer-generated block design [mixed block sizes]). An independent statistician
generated the randomization schedule, and individually numbered opaque envelopes were
produced. As participants were enrolled in the trial, the next envelope was placed into each
participant’s notes, which accompanied them to the operating theater. Once the surgeon had
confirmed satisfactory medial malleolus fracture reduction, after fibular stabilization (ⱕ2 mm
displacement on anteroposterior fluoroscopy), the envelope was opened by an independent theater
team member. If the medial malleolus fracture was not reduced within acceptable limits (n = 60),
the envelope was not opened and was returned, in order, to the randomization sequence, and the
patient was excluded.
Interventions
Patient care was supervised by a consultant orthopedic trauma surgeon, and all surgeons, including
trainees, were educated on the trial methods. Trial participants randomized intraoperatively to the
fixation group were treated with open reduction and internal fixation of the medial malleolus
fracture. The approach and implant type, including number and length of screws if used, were at the
surgeon’s discretion. Wound closure and postoperative management, including weight-bearing
prescription and immobilization, were also at their discretion. The default local postoperative
protocol advised immediate full weight-bearing in a removal orthosis unless a confirmed
syndesmotic injury, peripheral neuropathy, or significant associated soft tissue injury was identified.
Range-of-motion exercises were permitted from 2 weeks postoperatively. Trial participants
randomized intraoperatively to nonfixation had no medial fixation performed. Wound closure and
postoperative management were as per the fixation group.
Figure 1. CONSORT Diagram of Trial Participant Flow
884 Adult patients assessed

for eligibility
730 Excluded
304 No medial malleolus fracture
92 Declined inclusion
60 Unsatisfactory intraoperative medial malleolus
fracture reduction
53 Unable to comply with follow-up
53 Consultant felt inclusion in trial not in patient's
best interest
31 COVID-19 recruitment suspension
27 Unable to consent
26 Open fracture
23 Vertical medial malleolus fracture
17 Isolated medial malleolus fracture
14 Additional injury
14 Distal tibial intra-articular injury
9 Age <16 y
6 Surgery >2 wk after injury
1 Medically unfit for surgery
154 Randomized
78 Randomized to fixation 76 Randomized to nonfixation

78 Received allocated intervention 75 Received allocated intervention
0 Did not receive allocated intervention 1 Did not receive allocated intervention
2 Deceased 0 Deceased
4 Lost to follow-up 4 Lost to follow-up
72 Analyzed at 1 y 72 Analyzed at 1 y

Outcomes
Given the nature of the interventions, it was not practical to blind participants or outcome assessors
to allocation. Outcomes were collected in person at baseline, 6 weeks, and 1 year. Postal
questionnaires were completed at 3 and 6 months to minimize participant inconvenience. In some
situations, it was not possible to review participants in person at the final postoperative stage
because of SARS-CoV-2 pandemic hospital restrictions. In this situation, outcome scores were
collected by postal questionnaire, and participants were invited for radiographic review once it was
deemed safe.
The primary outcome was the Olerud-Molander Ankle Score (OMAS) at 1 year after
randomization.29 The OMAS is validated and extensively used in ankle trauma research. It assesses
outcome across 9 domains, including pain, stiffness, swelling, stair climbing, running, jumping,
squatting, supports, and work or activities of daily living. A score of 0 represents the worst possible
outcome and 100 represents the best possible outcome.
Secondary outcomes included the Manchester-Oxford Foot Questionnaire,30 with a score of 0
representing the best outcome and 100 representing the worst outcome, and the EuroQol-5D-3L
(EQ-5D) standardized instrument as a measure of health outcome,31 with a score of +1.0 representing
the best outcome or health and a score of −0.59 representing the worst. Assessment of pain, health,
and satisfaction was performed using a visual analog scale, ranging from 0 to 100, with 0
representing the worse score and 100 representing the best score. In those participants employed
and/or engaged in physical activity before injury, return time was recorded.
Complications were documented and classified as minor if they did not require further surgical
intervention or major if they required subsequent surgery. Minor complications included superficial
wound infection, wound dehiscence or delayed healing, implant prominence, localized pain, and
asymptomatic nonunion. Major complications included wound infection requiring debridement,
failed fixation resulting in loss of talar reduction, symptomatic nonunion, and symptomatic implants
requiring removal. Medical complications, including venous thromboembolism, were documented.
Radiographic outcomes included documentation of medial malleolar fracture type according to
the Herscovici classification20 and assessment of reduction quality based on intraoperative
fluoroscopy. Reduction quality was confirmed postoperatively by reviewing intraoperative
fluoroscopy and classified as anatomical, fair (ⱕ2-mm displacement), or poor (>2-mm
displacement).21,22 Postoperative computed tomography imaging was not performed routinely. Final
radiographs were used to assess fracture union and the development of posttraumatic osteoarthritis,
classified according to a modification of the Kellgren-Lawrence system, as described by Holzer
et al.32
Statistical Analysis
The trial was powered to detect a difference of 10 points in the OMAS 1 year after surgery between
the 2 groups. At the time of power calculation, no published minimum clinically important difference
(MCID) for the OMAS existed. However, after ankle fracture, a difference of 11 points had been
demonstrated in patients developing posttraumatic degeneration compared with those without.29
Consequently, a 10-point difference was chosen. A sample size of 128 participants (64 per group) was
required for 80% power, assuming an SD of 20,33 and 5% (2-sided) significance. The sample size was
increased by 20% to account for loss to follow-up, generating a sample size of 154. Intention-to-
treat analyses were performed.
The design of this trial assessed whether internal fixation of well-reduced medial malleolus
fractures after satisfactory fibular stabilization is superior to nonfixation. The primary outcome was
compared between groups using a 2-sample, unpaired t test or nonparametric equivalent, dictated
by data normality. Secondary outcomes were analyzed comparably. A sensitivity analysis was
performed based on the randomization stratification with an age cutoff of 65 years. Analysis of
covariance was used to examine the primary outcome adjusting for baseline demographics, preinjury
OMAS, and fracture classification. Comparison of binary outcomes, such as the presence of

nonunion, were performed using a binominal test for comparison of proportions. Mixed-model
analysis was performed by plotting the OMAS at multiple time points during recovery. Two-tailed P
values were presented, and P < .05 was used to indicate statistical significance. Analysis was
performed using SAS software, version 9.4 (SAS Institute Inc). Data analysis was performed in July
2022 and confirmed in September 2023.
Results
Among 154 participants randomized (mean [SD] age, 56.5 [16.7] years; 119 female [77%] and 35 male
[23%]), 144 (94%) completed the trial. Seventy-eight were allocated to fixation and 76 to
nonfixation (Figure 1). Baseline demographic, injury, and clinical characteristics were similar (Table 1),
including underlying comorbidities, such as diabetes, cardiac disease, kidney failure, and chronic liver
disease. There was 1 crossover for a participant randomized to nonfixation, but the medial malleolus
fracture was felt to redisplace when stressing the syndesmosis and therefore internally fixed. No
significant differences were found between intraoperative data except for a significantly reduced
tourniquet time in the nonfixation group (mean [SD] difference, −22.14 [5.70] minutes; 95% CI,
Table 1. Patient Characteristics at Baselinea
Characteristic Fixation (n = 78) Nonfixation (n = 76)

Age, mean (SD) [range], y 57.1 (16) [21-87] 55.9 (17) [19-92]
Sex
Male 13 (17) 22 (29)
Female 65 (83) 54 (71)
BMI, median (IQR) 26.2 (23.7-29.6) 28.6 (24.6-32.4)
Smoker 16 (21) 18 (24)
Alcohol intake 53 (68) 48 (63)
Engaged in employment pre-injury 42 (54) 39 (52)
Engaged in physical activity before injury 43 (55) 33 (43)
Baseline mean OMAS, mean (SD) [range] 94 (11) [55-100] 91 (15) [45-100]
Mechanism of injury
Fall standing height 66 (85) 63 (83)
Fall from height 3 (4) 1 (1)
Direct blow 1 (1) 2 (3)
Sport 7 (9) 9 (12)
Assault 1 (1.9) 0
Lauge-Hansen classification
Supination external rotation 71 (91) 62 (82)
Pronation external rotation 4 (5) 8 (10)
Pronation abduction 3 (4) 6 (8)
Supination adduction 0 0
AO/OTA classification
44B2 31 (40) 29 (38)
44B3 40 (51) 35 (46)
44C2 3 (4) 4 (5)
44C3 4 (5) 8 (11)
Herscovici medial malleolus classification
Type A 1 (1) 0 Abbreviations: AO/OTA, Arbeitsgemeinschaft für
Type B 45 (58) 43 (57) Osteosynthesefragen/Orthopaedic Trauma
Type C 30 (38) 29 (38) Association; BMI, body mass index (calculated as
weight in kilograms divided by height in meters
Type D 2 (3) 4 (5)
squared); OMAS, Olerud-Molander Ankle Score.
Posterior malleolus fracture present 45 (58) 47 (62)
a
Data are presented as number (percentage) of
Radiographic syndesmosis injury present 7 (9) 11 (14)
patients unless otherwise indicated.

−27.70 to −16.59 minutes; P < .001). Perioperative data are summarized in the eTable in
Supplement 2.
Primary Outcome
There were 72 trial participants analyzed in each group at the primary outcome point. Two
participants in the fixation group died during the study period from unrelated causes (cardiac event
and metastatic cancer). Four participants in each group could not be contacted. The median OMAS
was 80.0 (IQR, 60.0-90.0) in the fixation group and 72.5 (IQR, 55.0-90.0) in the nonfixation group
(Table 2). This difference of 7.5 was not statistically significant. A sensitivity analysis demonstrated
no significant difference between the groups when adjusting for an age cutoff of 65 years. Analysis of
covariance, adjusting for baseline OMAS, age, sex, and fracture classification, found no statistically
significant difference between the 2 groups (r2 = 0.156, P = .42). The mean OMAS was plotted during
the recovery using mixed-model analysis with treatment group and weeks as fixed effects and
participant as a random effect, with no difference found between groups (Figure 2).
Table 2. Trial Outcome Measures (Mann-Whitney U Test)
Median (IQR)
Outcome measure Fixation Nonfixation P value
Preoperative
OMAS 100 (55-100) 100 (45-100) .35
EQ-5D 1.00 (0.81-1.00) 1.00 (0.37-1.00) .29
6-8 Weeks
OMAS 40 (22.5-55) 40 (30-55) .38
MOXFQ 45 (27-63) 46 (29-65) .79
EQ-5D 0.69 (0.59-0.80) 0.66 (0.46-0.75) .21
Health 80 (70-90) 80 (65-90) .16
Pain 90 (70-95) 90 (70-93.5) .92
Satisfaction 100 (90-100) 100 (99.5-100) .23
12 Weeks
OMAS 50 (35-70) 55 (35-70) .72
MOXFQ 43 (24-59) 46 (27-64) .50
EQ-5D 0.69 (0.62-0.80) 0.69 (0.62-0.80) .99
Health 80 (70-90) 80 (70-90) .56
Pain 80 (60-90) 80 (60-90) .55
Satisfaction 90 (80-100) 90 (80-100) .55
26 Weeks
OMAS 65 (50-80) 65 (40-80) .64
MOXFQ 28 (9-24) 34 (13-50) .29
EQ-5D 0.76 (0.69-0.80) 0.73 (0.69-0.80) .53
Health 90 (70-90) 80 (70-95) .21
Pain 90 (70-95) 80 (60-90) .12
Satisfaction 90 (90-100) 90 (90-100) .48
52 Weeks
OMAS 80 (60-90) 72.5 (55-90) .17
MOXFQ 12 (2-32) 19 (5-41) .16
EQ-5D 0.85 (0.71-1.00) 0.80 (0.70-0.85) .05
Health 90 (80-95) 90 (70-95) .23
Pain 95 (90-100) 90 (77.5-100) .55
Satisfaction 100 (90-100) 100 (90-100) .90
Return to work (weeks) 9 (4-12) 9 (6-12) .60 Abbreviations: EQ-5D, EuroQol-5D-3L; MOXFQ,
Manchester-Oxford Foot Questionnaire; OMAS,
Return to sport (weeks) 12 (10-20) 12 (8-15) .28
Olerud-Molander Ankle Score.

Secondary Outcomes
With the exception of the 1-year EQ-5D score, which favored fixation (median score, 0.85 vs 0.80;
P = .049), there was no significant difference in any of secondary outcome measures between the
groups at any time point. Similarly, the proportion of patients returning to work and activity,
including return time, were comparable (Table 2).
Complications and Adverse Events

In total, 43 participants (60%) in the fixation group experienced 1 or more complications within 1
year of surgery compared with 45 (63%) in the nonfixation group (odds ratio [OR], 0.89; 95% CI,
0.46-1.74; P = .73) (Table 3). Four patients in the fixation group and 9 patients in the nonfixation
group experienced a major complication (OR, 0.41; 95% CI, 0.12-1.40; P = .16). Localized medial pain
was more common in the fixation group, but this finding was not statistically significant (16 patients
[22%] in the fixation group vs 8 patients [11%] in the nonfixation group; OR, 2.29; 95% CI, 0.91-5.74;
P = .08). Two patients in the fixation group required implant removal because of screw backout and
irritation of the tibialis posterior tendon, respectively.
Radiographic Outcomes
Because of the impact of the SARS-CoV-2 pandemic, radiographic data were available from 67
participants in the fixation group and 65 participants in the nonfixation group (86% in both groups)
(Table 3). Some participants declined review because of ongoing concerns regarding the pandemic,
in particular elderly patients and/or those with significant comorbidities. Lateral malleolar union
occurred in all patients. Medial-sided union was achieved in 52 of 65 cases (80%) in the nonfixation
group (eFigure 1 in Supplement 2) and all cases in the fixation group. Of the 13 patients (20%) who
developed a nonunion, 8 had no localized symptoms and were classed as having asymptomatic
nonunions (eFigure 2 in Supplement 2). Of the 5 participants with localized symptoms, 1 required
further surgery, whereby the nonunited distal fragment was excised with improvement. All
nonunions were type B fractures according to the Herscovici classification.20 Five nonunions
occurred in 13 smokers (39%) compared with 8 nonunions in 52 nonsmokers (15%; OR, 3.44; 95% CI,
0.89-13.22; P = .07). We found no between-group difference in posttraumatic osteoarthritis (17
patients [25%] in the fixation group vs 17 patients [26%] in the nonfixation group; OR, 0.96; 95% CI,
0.44-2.10; P = .92) 1 year after surgery (Table 3).
Figure 2. Mixed-Model Analysis
100
Nonfixation
Fixation
80
60
Total OMAS
40
20
Mixed-model analysis demonstrating change in mean

0
0 6 12 26 52 Olerud-Molander Ankle Score (OMAS) over time by
Week treatment group. Shaded areas indicate 95% CIs.

Effect of Medial Malleolar Nonunion and Reduction Quality

Participants with a radiographic nonunion at 1 year (n = 13) had a poorer median OMAS of 70.0 (IQR,
30.0-72.5) compared with 80.0 (IQR, 55.0-80.0) in those with radiographic union (P = .01).
Participants with painful nonunion (n = 5) had a significantly poorer median OMAS of 20.0 (IQR,
5.0-55.0), and participants who developed an asymptomatic medial malleolar nonunion had a
median OMAS of 70.0 (IQR, 67.5-80.0), which was comparable to 75.0 (IQR, 55.0-90.0) in the union
group (P = .54). There was no difference between the type of medial malleolar fracture type
(Herscovici types A-D) and the primary outcome. Intraoperative fracture reduction quality
significantly affected the OMAS at 1 year (anatomical: 80.0 [IQR, 70.0-97.5], fair: 60.0 [IQR, 47.5-
80.0], and poor: 60.0 [IQR, 32.5-80.0]; P = .008), although the study was not powered to detect a
difference between fracture types or reduction quality. Participants in the nonfixation group with
type C fractures that reduced anatomically (n = 17) all united (eFigure 1 in Supplement 2) and
achieved satisfactory functional outcome.
Table 3. Complications and Radiographic Outcomes
No. (%) of patients

Outcome Fixation (n = 72) Nonfixation (n = 72)
Minor complications (no requirement for surgery)
Superficial infection
Lateral 8 (11) 9 (13)
Medial 5 (7) 1 (1)
Wound dehiscence
Lateral 2 (3) 2 (3)
Medial 0 0
Implant prominence
Lateral 19 (26) 19 (26)
Medial 11 (15) 0
Localized pain
Lateral 7 (10) 14 (19)
Medial 16 (22) 8 (11)
Major complications (requirement for surgery)
Deep infection requiring surgery
Lateral 1 (1) 2 (3)
Medial 0 0
Loss of talar reduction requiring revision 0 3 (4)
Medial malleolar nonunion requiring surgery 0 1 (1)
Removal of symptomatic implants
Lateral 1 (1) 3 (4)
Medial 2 (3) 0
Radiographic outcomesa
Radiographic nonunion
Lateral 0 0
Medial 0 13 (20)
Symptomatic nonunion
Lateral 0 0
Medial 0 5 (8)
New radiographic degeneration
Overall 17 (25) 17 (26)
Grade 1 12 (18) 10 (15)
Grade 2 4 (6) 4 (6)
Grade 3 1 (1) 0
a
Sample sizes for radiographic outcomes are 67 for
Grade 4 0 3 (5)
the fixation group and 65 for the nonfixation group.

Discussion
The primary outcome of this study does not support the hypothesis that fixation of well-reduced
medial malleolus fractures is superior to nonfixation in the surgical management of unstable ankle
fractures. However, a 20% radiographic nonunion rate after nonfixation is notable, and although the
rate of reintervention for this was low because of it being asymptomatic in most cases, the future
implications are unclear. The findings support selective nonfixation of anatomically reduced
fractures, with longer-term follow-up required to validate these findings.
The results of the current trial somewhat contrast with those from the study by Hoelsbrekken
23
et al, who reported a similar OMAS in the fixation group (mean score, 80.0) but a superior, yet not
statistically so, OMAS in the nonfixation group (mean score, 81.0). The aforementioned trial
published mean OMAS values compared with median values in the current trial, making it difficult to
draw strict comparisons. The nonunion rate in the nonfixation group was also lower than that in the
current study (9% vs 20%), but the current study has likely overestimated this, as acknowledged in
the Limitations section. Carter et al22 retrospectively compared nonfixation with fixation of medial
malleolus fractures after fibular nail fixation. In that study of 54 patients treated nonoperatively, a
median OMAS of 85.0 compared favorably with 80.0 in the fixation group, which included 193
patients. However, the study was limited by loss to follow-up and potential patient selection bias. In
the current study, quality of life measured by the EQ-5D improved in the fixation group, particularly
at 1 year; however, this finding was below the published MCID.34 Longer-term surveillance of quality
of life will be important because deterioration may reflect chronic ankle issues, including
posttraumatic degeneration.
Pinski et al24 reviewed 257 patients, 87 of whom had a medial malleolus fracture that was
treated without fixation after fibular stabilization, and reported pain scores rather than functional
outcome. In contrast to the results of the current trial, nonoperative treatment of supracollicular
fractures, similar to Herscovici type C injuries, was associated with increased pain compared with
fixation. We cannot explain these differences with data from the current trial, because type C
fractures were successfully treated conservatively without increased risk of nonunion, pain, or poor
functional outcome. We hypothesize that the larger metaphyseal fracture bed aids union and is less
likely to have periosteum interposed, in contrast with smaller and more distal type B fractures. In a
study of 57 conservatively managed cases, Herscovici et al20 found a nonunion rate of only 4%
(n = 2). Both were type C fractures but were displaced by 3 and 4 mm, respectively, making it difficult
to draw comparisons with the current trial and suggesting that any difference is likely due to chance.
When considering all fracture types and reduction quality as a group, the OMAS difference at 1
year was 7.5, which was not statistically significant or clinically relevant as defined by a 10-point
margin in the OMAS. However, although this trial was not powered to compare individual medial
fracture types and reduction quality, there was a trend highlighting comparable rates of union and
functional outcome in type C fractures that remain well reduced after fibular stabilization. This
finding should inform future research on this topic.
The rate of soft tissue complications after fixation was not significantly higher than with
nonfixation. Localized medial-sided pain was twice as common after fixation, but this finding did not
reach statistical significance. Although the results of this trial suggest that internal fixation is not
required in well-reduced medial malleolar fractures, fixation was not associated with unacceptably
high numbers of complications, particularly related to implant removal. Our center recommends
additional surgery only for intolerable symptoms, which may explain why only 2 patients in the
fixation group required implant removal. All internally fixed fractures were approached via open
reduction and not percutaneously. Although percutaneous fixation is associated with a risk of
delayed union,35 it has been shown to be safe,36,37 and future level 1 research comparing nonfixation
with percutaneous fixation would meaningfully add to the literature. Finally, operative time in the
nonfixation group was a mean of 22.14 minutes shorter. This difference could not only impart
benefits for patients but also positively influence operating room flow, costs, and productivity.

Limitations
This trial has limitations. The study was powered to detect a 10-point difference in the OMAS at 1
year. Since trial completion, MCID values for the OMAS after ankle fracture have been published,
ranging from 4.3 to 11.4, influenced by timing and method of calculation after injury.38-40 A difference
of 7.5 points in the current trial may therefore be viewed as clinically significant dependent on which
MCID value is referenced. The results collected were from a single center and therefore may not
represent general orthopedic practice, although patient care was supervised by 12 orthopedic
trauma surgeons and followed a pragmatic approach. Reflecting this design, 5 participants in the
nonfixation group were included in the analysis despite demonstrating poor reduction (>2-mm
displacement) because the surgeon had deemed the reduction satisfactory intraoperatively. The
inclusion of these patients may have influenced functional outcome and overestimated the nonunion
rate. To reduce postoperative stiffness, patients were permitted to perform range-of-motion
exercises out of their removable orthoses at 2 weeks after surgery. This may have increased fracture
site motion in the nonfixation group, contributing to the nonunion rate. Given the nature of the
interventions, blinding was not logistically possible, particularly for the primary outcome measure
used. We excluded 26 patients with open fractures (4% of the excluded group), with most having a
medial laceration. Considering the potential for increased soft tissue complications with these
injuries, nonfixation may in fact be more beneficial to this specific cohort.41 Although patient
outcomes, including complications, have been documented to 1 year, the implications of a clinically
silent radiographic nonunion may not be recognized for several years, and longer-term surveillance is
required. For participants in the fixation group, numerous surgeons saved only final intraoperative
imaging, and consequently a retrospective assessment of the medial malleolar reduction for quality
control purposes cannot be performed in the same manner as for the nonfixation group. Finally,
some authors have identified issues with fracture malreduction when performing postoperative
computed tomography imaging.42,43 Computed tomography was not performed in the current trial
but may be considered in futures studies of this nature.
Conclusions
In this randomized clinical trial of patients with unstable ankle fractures involving well-reduced
medial malleolus fracture, internal fixation after fibular stabilization did not significantly improve
functional outcomes 1 year after surgery. However, the nonunion rate and associated patient-
reported outcome are important findings and could be influenced by fracture type and reduction
quality, which must be scrutinized radiographically before electing to treat without fixation.
Consequently, we caution against nonfixation in fractures that remain displaced after fibular
stabilization. Future follow-up and monitoring for posttraumatic degeneration and its implications is
recommended.
ARTICLE INFORMATION
Accepted for Publication: November 21, 2023.
Published: January 18, 2024. doi:10.1001/jamanetworkopen.2023.51308
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2024 Carter TH
et al. JAMA Network Open.
Corresponding Author: Thomas H. Carter, MD, Edinburgh Orthopaedic Trauma, Royal Infirmary of Edinburgh,
Edinburgh EH16 4SA, UK (carter.tom@doctors.org.uk).
Author Affiliations: Edinburgh Orthopaedic Trauma, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom
(Carter, Oliver, Bell, Duckworth, White); Edinburgh Clinical Research Facility, Western General Hospital, Edinburgh,
United Kingdom (Graham); Centre for Population Health Sciences, Usher Institute, University of Edinburgh,
Edinburgh, United Kingdom (Duckworth).

Author Contributions: Dr Carter and Ms Graham had full access to all of the data in the study and take
responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Carter, Graham, Duckworth, White.
Acquisition, analysis, or interpretation of data: Carter, Oliver, Bell, Duckworth, White.
Drafting of the manuscript: All authors.
Critical review of the manuscript for important intellectual content: Carter, Duckworth, White.
Statistical analysis: Graham.
Obtained funding: Carter, Duckworth, White.
Administrative, technical, or material support: Carter, Oliver, Bell, Duckworth, White.
Supervision: Graham, Duckworth, White.
Conflict of Interest Disclosures: Dr Duckworth reported that Edinburgh Orthopaedics receives or has received
funding support for education or research from Acumed, Smith & Nephew, and Stryker. Dr Duckworth reported
receiving educational payments for elbow courses from Smith & Nephew and Swemac. No other disclosures were
reported.
Funding/Support: This study was funded by educational grant 17004 from Acumed (Drs Carter and White).
Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection,
management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and
decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
Additional Contributions: Emily Evans, MSc, Edinburgh Clinical Research Facility, Western General Hospital,
Edinburgh, United Kingdom, assisted with the statistical analysis. She was not compensated directly, but the
Edinburgh Clinical Research Facility received compensation for their assistance with data analysis. Keri Swain and
Debbie Ketchen, Scottish Orthopaedic Research Trust into Trauma (SORT-IT), assisted with trial administration.
They are paid employees of SORT-IT but did not receive any money directly from the trial.
REFERENCES
1. Court-Brown CM, Caesar B. Epidemiology of adult fractures: a review. Injury. 2006;37(8):691-697. doi:10.1016/
j.injury.2006.04.130
2. Donken CC, Al-Khateeb H, Verhofstad MH, van Laarhoven CJ. Surgical versus conservative interventions for
treating ankle fractures in adults. Cochrane Database Syst Rev. 2012;(8):CD008470. doi:10.1002/14651858.
CD008470.pub2
3. Barbosa P, Bonnaire F, Kojima K. Malleoli: infrasyndesmotic, medial fracture with lateral fracture/avulsion.
Accessed September 1, 2018. https://surgeryreference.aofoundation.org/orthopedic-trauma/adult-trauma/
malleoli/infrasyndesmotic-medial-fracture-with-lateral-fracture-avulsion/definition
4. Ricci WM, Tornetta P, Borrelli J Jr. Lag screw fixation of medial malleolar fractures: a biomechanical,
radiographic, and clinical comparison of unicortical partially threaded lag screws and bicortical fully threaded lag
screws. J Orthop Trauma. 2012;26(10):602-606. doi:10.1097/BOT.0b013e3182404512
5. Parada SA, Krieg JC, Benirschke SK, Nork SE. Bicortical fixation of medial malleolar fractures. Am J Orthop (Belle
Mead NJ). 2013;42(2):90-92.
6. King CM, Cobb M, Collman DR, Lagaay PM, Pollard JD. Bicortical fixation of medial malleolar fractures: a review
of 23 cases at risk for complicated bone healing. J Foot Ankle Surg. 2012;51(1):39-44. doi:10.1053/j.jfas.2011.
09.007
7. Parker L, Garlick N, McCarthy I, Grechenig S, Grechenig W, Smitham P. Screw fixation of medial malleolar
fractures: a cadaveric biomechanical study challenging the current AO philosophy. Bone Joint J. 2013;95-B(12):
1662-1666. doi:10.1302/0301-620X.95B12.30498
8. Wera JC, Seligson D, Riehl JT. Medial malleolus screws: out in one view and out. Eur J Orthop Surg Traumatol.
2015;25(7):1189-1193. doi:10.1007/s00590-015-1673-7
9. Ostrum RF, Litsky AS. Tension band fixation of medial malleolus fractures. J Orthop Trauma. 1992;6(4):
464-468. doi:10.1097/00005131-199212000-00013
10. Georgiadis GM, White DB. Modified tension band wiring of medial malleolar ankle fractures. Foot Ankle Int.
1995;16(2):64-68. doi:10.1177/107110079501600202
11. Johnson BA, Fallat LM. Comparison of tension band wire and cancellous bone screw fixation for medial
malleolar fractures. J Foot Ankle Surg. 1997;36(4):284-289. doi:10.1016/S1067-2516(97)80074-9

12. Barnes H, Cannada LK, Watson JT. A clinical evaluation of alternative fixation techniques for medial malleolus
fractures. Injury. 2014;45(9):1365-1367. doi:10.1016/j.injury.2014.05.031
13. Cheng RZ, Wegner AM, Behn AW, Amanatullah DF. Headless compression screw for horizontal medial
malleolus fractures. Clin Biomech (Bristol, Avon). 2018;55:1-6. doi:10.1016/j.clinbiomech.2018.03.023
14. Tekin AC, Çabuk H, Dedeoğlu SS, et al. Anterograde headless cannulated screw fixation in the treatment of
medial malleolar fractures: evaluation of a new technique and its outcomes. Med Princ Pract. 2016;25(5):429-434.
doi:10.1159/000447426
15. Li ZH, Yu AX, Guo XP, Qi BW, Zhou M, Wang WY. Absorbable implants versus metal implants for the treatment
of ankle fractures: a meta-analysis. Exp Ther Med. 2013;5(5):1531-1537. doi:10.3892/etm.2013.1017
16. Clyde J, Kosmopoulos V, Carpenter B. A biomechanical investigation of a knotless tension band in medial
malleolar fracture models in composite Sawbones®. J Foot Ankle Surg. 2013;52(2):192-194. doi:10.1053/j.jfas.2012.
11.001
17. Downey MW, Duncan K, Kosmopoulos V, et al. Comparing the knotless tension band and the traditional
stainless steel wire tension band fixation for medial malleolus fractures: a retrospective clinical study. Scientifica
(Cairo). 2016;2016:3201678. doi:10.1155/2016/3201678
18. May H, Alper Kati Y, Gumussuyu G, Yunus Emre T, Unal M, Kose O. Bioabsorbable magnesium screw versus
conventional titanium screw fixation for medial malleolar fractures. J Orthop Traumatol. 2020;21(1):9. doi:10.1186/
s10195-020-00547-7
19. Herber V, Labmayr V, Sommer NG, et al. Can hardware removal be avoided using bioresorbable Mg-Zn-Ca
screws after medial malleolar fracture fixation? mid-term results of a first-in-human study. Injury. 2022;53(3):
1283-1288. doi:10.1016/j.injury.2021.10.025
20. Herscovici D Jr, Scaduto JM, Infante A. Conservative treatment of isolated fractures of the medial malleolus.
J Bone Joint Surg Br. 2007;89(1):89-93. doi:10.1302/0301-620X.89B1.18349
21. Hanhisuanto S, Kortekangas T, Pakarinen H, Flinkkilä T, Leskelä HV. The functional outcome and quality of life
after treatment of isolated medial malleolar fractures. Foot Ankle Surg. 2017;23(4):225-229. doi:10.1016/j.fas.
2016.06.004
22. Carter THMS, Mackenzie SP, Bell KR, et al. Selective fixation of the medial malleolus in unstable ankle fractures.
Injury. 2019;50(4):983-989. doi:10.1016/j.injury.2019.03.010
23. Hoelsbrekken SE, Kaul-Jensen K, Mørch T, et al. Nonoperative treatment of the medial malleolus in bimalleolar
and trimalleolar ankle fractures: a randomized controlled trial. J Orthop Trauma. 2013;27(11):633-637. doi:10.1097/
BOT.0b013e31828e1bb7
24. Pinski JM, Ryan SP, Pittman JL, Tornetta P. Is fixation of the medial malleolus necessary in unstable ankle
fractures? Arch Orthop Trauma Surg. 2023;143(6):2999-3005. doi:10.1007/s00402-022-04528-9
25. Davidovitch RI, Egol KA. The medial malleolus osteoligamentous complex and its role in ankle fractures. Bull
NYU Hosp Jt Dis. 2009;67(4):318-324.
26. Tornetta P III. Competence of the deltoid ligament in bimalleolar ankle fractures after medial malleolar
fixation. J Bone Joint Surg Am. 2000;82(6):843-848. doi:10.2106/00004623-200006000-00011
27. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for
reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-677. doi:10.1016/j.ijsu.2011.09.004
28. Carter TH, Oliver WM, Graham C, Duckworth AD, White TO. Medial malleolus: Operative Or Non-operative
(MOON) trial protocol—a prospective randomised controlled trial of operative versus non-operative management
of associated medial malleolus fractures in unstable fractures of the ankle. Trials. 2019;20(1):565. doi:10.1186/
s13063-019-3642-7
29. Olerud C, Molander H. A scoring scale for symptom evaluation after ankle fracture. Arch Orthop Trauma Surg
(1978). 1984;103(3):190-194. doi:10.1007/BF00435553
30. Dawson J, Coffey J, Doll H, et al. A patient-based questionnaire to assess outcomes of foot surgery: validation
in the context of surgery for hallux valgus. Qual Life Res. 2006;15(7):1211-1222. doi:10.1007/s11136-006-0061-5
31. Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33(5):
337-343. doi:10.3109/07853890109002087
32. Holzer N, Salvo D, Marijnissen ACA, et al. Radiographic evaluation of posttraumatic osteoarthritis of the ankle:
the Kellgren-Lawrence scale is reliable and correlates with clinical symptoms. Osteoarthritis Cartilage. 2015;23(3):
363-369. doi:10.1016/j.joca.2014.11.010

33. Willett K, Keene DJ, Mistry D, et al; Ankle Injury Management (AIM) Trial Collaborators. Close contact casting
vs surgery for initial treatment of unstable ankle fractures in older adults: a randomized clinical trial. JAMA.
2016;316(14):1455-1463. doi:10.1001/jama.2016.14719
34. Walters SJ, Brazier JE. Comparison of the minimally important difference for two health state utility measures:
EQ-5D and SF-6D. Qual Life Res. 2005;14(6):1523-1532. doi:10.1007/s11136-004-7713-0
35. Weinraub GM, Levine P, Shi E, Flowers A. Comparison of medial malleolar fracture healing at 8 weeks after
open reduction internal fixation versus percutaneous fixation: a retrospective cohort study. J Foot Ankle Surg.
2017;56(2):277-281. doi:10.1053/j.jfas.2016.11.003
36. Matson AP, Barchick SR, Adams SB. Comparison of open reduction and internal fixation versus closed
reduction and percutaneous fixation for medial malleolus fractures. J Am Acad Orthop Surg Glob Res Rev. 2017;1
(8):e048.
37. Smith M, Medlock G, Johnstone AJ. Percutaneous screw fixation of unstable ankle fractures in patients with
poor soft tissues and significant co-morbidities. Foot Ankle Surg. 2017;23(1):16-20. doi:10.1016/j.fas.2015.11.008
38. Gausden EB, Levack A, Nwachukwu BU, Sin D, Wellman DS, Lorich DG. Computerized adaptive testing for
patient reported outcomes in ankle fracture surgery. Foot Ankle Int. 2018;39(10):1192-1198. doi:10.1177/
1071100718782487
39. McKeown R, Parsons H, Ellard DR, Kearney RS. An evaluation of the measurement properties of the Olerud
Molander Ankle Score in adults with an ankle fracture. Physiotherapy. 2021;112:1-8. doi:10.1016/j.physio.2021.
03.015
40. Penning D, Kleipool S, van Dieren S, Dingemans SM, Schepers T; RODEO Collaborator Group. The minimal
clinically important difference (MCID) of the Olerud Molander Ankle Score (OMAS) in patients with unstable ankle
fracture. Arch Orthop Trauma Surg. 2023;143(6):3103-3110. doi:10.1007/s00402-022-04533-y
41. Carter TH, Arthur CH, Duckworth AD, White TO. To fix or not to fix: a novel approach to the safe management
of unstable open medial malleolar fractures. BMJ Case Rep. 2019;12(4):e228965. doi:10.1136/bcr-2018-228965
42. Palmanovich E, Brin YS, Kish B, Nyska M, Hetsroni I. Value of early postoperative computed tomography
assessment in ankle fractures defining joint congruity and criticizing the need for early revision surgery. J Foot
Ankle Surg. 2016;55(3):465-469. doi:10.1053/j.jfas.2016.01.013
43. Abbasian M, Biglari F, Sadighi M, Ebrahimpour A. Reliability of postoperative radiographies in ankle fractures.
Arch Bone Jt Surg. 2020;8(5):598-604.
SUPPLEMENT 1.
Trial Protocol
SUPPLEMENT 2.
eTable. Perioperative Data for the MOON Trial
eFigure 1. A Radiographic Example of a Type-C Medial Malleolar Fracture That Progressed to Satisfactory
Radiographic Union
eFigure 2. A Radiographic Example of a Type-B Medial Malleolar Fracture That Progressed to an Asymptomatic
Radiographic Nonunion
SUPPLEMENT 3.
Data Sharing Statement

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Original Investigation | Orthopedics

Operative vs Nonoperative Management of Unstable Medial Malleolus Fractures

Abstract Key Points

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TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03362229

JAMA Network Open. 2024;7(1):e2351308. doi:10.1001/jamanetworkopen.2023.51308

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Figure 1. CONSORT Diagram of Trial Participant Flow

884 Adult patients assessed

78 Randomized to fixation 76 Randomized to nonfixation

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Table 1. Patient Characteristics at Baselinea

Characteristic Fixation (n = 78) Nonfixation (n = 76)

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Table 2. Trial Outcome Measures (Mann-Whitney U Test)

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Complications and Adverse Events

Figure 2. Mixed-Model Analysis

Mixed-model analysis demonstrating change in mean

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Effect of Medial Malleolar Nonunion and Reduction Quality

Table 3. Complications and Radiographic Outcomes

No. (%) of patients

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