Early Weightbearing Versus Nonweightbearing After Operative Treatment of an Ankle Fracture: A Multicenter, Noninferiority, Randomized Controlled Trial
Abstract
Background: Acute ankle fractures can occur during sports activities, and unstable ankle fractures are commonly treated operatively. However, controversy exists about the optimal time to allow weightbearing. Hypothesis: Early weightbearing after the stable fixation of an ankle fracture is not inferior to nonweightbearing in terms of ankle function assessed at 12 months after injury. Study design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 258 patients were assessed for eligibility. Of these patients, 194 were randomly allocated to either the early weightbearing group (95 patients who were allowed weightbearing at 2 weeks postoperatively) or the nonweightbearing group (99 patients who were not allowed weightbearing until 6 weeks postoperatively). The primary outcome measure was the mean difference in the Olerud-Molander ankle score (OMAS) between the groups, assessed at the 12-month follow-up examination. The secondary outcome measures were the time to return to preinjury activities and patients’ subjective satisfaction. Complications such as hardware loosening or failure, fracture displacement, and nonunion were evaluated. Results: The mean difference in the OMAS for the early weightbearing group compared with the nonweightbearing group was 1.6 (95% CI, –1.9 to 5.0) in the intention-to-treat analysis. The lower limit of the 95% CI (–1.9) exceeded the noninferiority margin of –8, indicating that early weightbearing was not inferior to…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 258 participants or records.
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