Operative Versus Nonoperative Treatment of Unstable Lateral Malleolar Fractures: A Randomized Multicenter Trial

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Objectives:To compare clinical and functional outcomes after operative and nonoperative treatment of undisplaced, unstable, isolated fibula fractures.Design:Randomized multicenter clinical trial.Setting:Six level 1 trauma centers.Patients/Participants:Eighty-one patients with undisplaced, unstable, isolated fibula fractures as confirmed by an external rotation stress examination demonstrating an increase in medial clear space to 5 mm or greater were followed for 12 months after treatment.Intervention:Forty-one patients were treated operatively by open reduction and internal fixation of the fibula. Forty patients underwent nonoperative treatment, which included the use of a short leg cast or brace and protected weight bearing for 6 weeks.Main Outcome Measurements:Functional outcomes determined using the Olerud–Molander Ankle Score and the Short Form 36. Radiographic outcomes included measurement of union and displacement at each visit.Results:There were no statistically significant differences in functional outcome scores or pace of recovery between the operative and nonoperative groups at any time interval (β = −0.28, 3.49; P = 0.936). Complications in the nonoperative group included 8 patients with a medial clear space ≥5 mm and 8 patients with delayed union or nonunion. In the operative group, 5 patients had a surgical site infection and 5 patients required hardware removal.Conclusions:Patients managed operatively had equivalent functional outcomes compared with nonoperative treatment; however, the risk of displacement and problems with union was substantially lower in patients managed with surgery.

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