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To compare clinical and functional outcomes after operative and nonoperative treatment of undisplaced, unstable, isolated fibula fractures. Randomized multicenter clinical trial. Six level 1 trauma centers. 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. 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. 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. 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. 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.
Stability is a key issue in treating supination-external rotation ankle fractures, but we do not know how it affects functional outcome and subsequent development of radiographic osteoarthritis. With a systematic literature review, we identified 11 clinical studies (Level IV evidence) published in peer-reviewed journals reporting on at least 10 ankles. Followup was at least 1 year. Two authors independently scored the quality of the studies using the modified Coleman Methodology Score; the mean score was 58 of 100, with substantial agreement between the two examiners. Four studies used a general health assessment questionnaire. Several literature limitations (debatable fracture stability criteria, few cohort studies with heterogeneous methodology, small patient numbers and limited followup in some studies) do not allow definitive conclusions. Of 213 stable fractures treated nonoperatively, 2.8% of ankles had radiographic osteoarthritis develop (18 years' mean followup) and 84% were free of symptoms. The incidence of radiographic osteoarthritis in 420 unstable fractures treated operatively was 20.9% at 5.5 years versus 65.5% at 6.8 years in 137 ankles treated nonoperatively. The complication rate in 355 operatively treated fractures was 10.4%. A medial malleolus fracture, female gender, older age, higher American Society of Anesthesiologists grade, smoking, and lower educational level negatively influenced general health outcome, physical function, and pain. Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
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