Fri., 10/15/10 Foot & Ankle, Paper #48, 11:14 am OTA-2010
Operative versus Nonoperative Treatment of Unstable Lateral Malleolar Fractures: A Randomized, Multicenter Trial
David W. Sanders, MD; Christina A. Tieszer; Canadian Orthopedic Trauma Society;
University of Western Ontario, London, Ontario, Canada
Purpose: The preferred treatment for undisplaced but unstable lateral malleolar fractures is controversial. The purpose of this study was to compare functional outcomes following surgical and nonsurgical treatment of undisplaced, potentially unstable, isolated fibula fractures in an adult population. Secondary objectives were to compare the radiographic outcomes and complications between the two groups.
Methods: This registered clinical trial enrolled 81 patients, 18 to 65 years of age, at 6 sites. Institutional Review Board approval was obtained. Prior to randomization, all patients had injury films with no evidence of talar shift, followed by an external rotation stress radiograph demonstrating an increase in the medial clear space to 5 mm or greater. 41 patients were randomized to operative repair, which included open reduction and internal fixation of the fibula. Forty patients were treated nonoperatively, including use of a short-leg cast or brace and protected weight bearing for a minimum of 6 weeks. Clinical and radiographic review was performed at 6, 12, 24, and 52 weeks. Clinical outcomes included the Olerud and Molander ankle score and Short Form-36 (SF-36). Radiographic outcomes included measurement of union and displacement at each visit. Statistical analysis included analysis of variance of means and standard deviations at each time interval, as well as analysis of the slope of the recovery curve with multiple logistical regression analyses.
Results: The mean (± SD) SF-36 physical component summary score for all patients was 45 ± 19 at 6 weeks, 63 ± 19 at 3 months, 76 ± 19 at 6 months, and 79 ± 19 at 1 year. The overall Olerud-Molander score improved from 37 ± 20 at 6 weeks to 84 ± 22 at 1 year. There were no differences in functional outcome scores or pace of recovery between the operative and nonoperative groups at any time interval. Radiographs demonstrated 8 patients with a medial clear space ≥5 mm in the nonoperative group. One patient in the operative group had an increase in tibiofibular clear space. Complications in the nonoperative group included 8 patients with delayed union or nonunion. In the operative group, 5 patients had a surgical site infection, of which 4 were superficial. Five patients required hardware removal.
Conclusions: Functional outcome following unstable, undisplaced fractures of the lateral malleolus demonstrated ongoing recovery 12 months following injury. Patients managed operatively had equivalent functional outcomes compared to nonoperative treatment; however, the risk of displacement and problems with union was substantially lower in patients managed with surgery.
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• The FDA has not cleared this drug and/or medical device for the use described in this presentation (i.e., the drug or medical device is being discussed for an “off label” use). ◆FDA information not available at time of printing. Δ OTA Grant.