A Prospective Randomized Trial to Assess Early versus Delayed Weight Bearing Following Operatively Treated Ankle Fractures in the United States.

OBJECTIVES: To determine the safety of early versus delayed weight bearing and effectiveness for improving return-to-work following ankle fracture repair.

METHODS: Design: Prospective randomized study.

SETTING: 19 United States Trauma Centers.

PATIENT SELECTION CRITERIA: Adult patients (≥18 years) with ankle fracture (OTA/AO 44 A, B or C) undergoing surgical fixation were included. Open Gustilo-Anderson (G-A) Type IIIB, IIIC, syndesmotic injuries with fixation, and injuries with arterial impaction that surgeons felt unsafe to weight were excluded.

OUTCOME MEASURES AND COMPARISONS: The co-primary outcomes were (1) non-inferiority of early versus delayed weight bearing for reoperation for complications of hardware failure, non-union, loss of reduction, infection, or fusion; and (2) gated superiority of early versus delayed weight bearing for time to return-to-work, both within 365 days of randomization. Reoperation and time to return-to-work was compared between patients assigned to early (2 weeks post-operatively) versus delayed (6 weeks post-operatively) weight bearing.

RESULTS: The modified intent to treat sample included 418 patients enrolled between January 2020 through October 2023; 214 early (mean age: 47; SD (15) range (18-84); 35% male); 204 delayed (mean age: 43; SD (15); 36% male). Reoperation for complication occurred in 5 early (2.3%, 95% Confidence Interval (CI): 0.3%, 4.4%), and 7 delayed patients (3.4%, 95% CI: 0.9%, 5.9%). Median time to return-to-work (95% CI) was 54 (42, 77) days and 69 (47, 89) days for the early and delayed groups, respectively. Early weight bearing was non-inferior to delayed weight bearing for reoperation (difference in complication free survival (early - delayed): 1.5 percentage points; 90% two sided CI: -1.7%, 4.8% which excluded the non-inferiority tolerance of -5.0%) and not superior for return-to-work (Hazard Ratio 1.1, 95% CI: 0.8, 1.6, p=0.475).

CONCLUSIONS: Trial findings add to the growing evidence demonstrating the safety of early weight bearing after fixation of bimalleolar and trimalleolar ankle fracture without syndesmotic disruption, a key concern for both clinicians and patients. However, no statistically significant benefit of earlier return-to-work was found.

LEVEL OF EVIDENCE: I.