Operative versus nonoperative treatment of unstable lateral malleolar fractures: a randomized multicenter trial.

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.