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NOT YET RECRUITING
NCT07811804
NA

Early Ambulation Safely in Unstable Ankle Fractures (EASY-Ankle)

Sponsor: Ottawa Hospital Research Institute

View on ClinicalTrials.gov

Summary

This pilot randomized controlled trial will evaluate the safety and feasibility of beginning weight-bearing earlier after surgery for an unstable trimalleolar ankle fracture. Trimalleolar ankle fractures involve three parts of the ankle and usually require surgery to restore and stabilize the joint. After surgery, patients are commonly instructed not to place weight on the injured ankle for approximately six weeks. However, earlier weight-bearing may improve mobility and recovery without increasing complications. Additional evidence is needed specifically for patients with trimalleolar fractures. Participants will be randomly assigned in a 1:1 ratio to one of two postoperative rehabilitation groups. The early weight-bearing group will begin placing weight on the injured ankle two weeks after surgery. The delayed weight-bearing group will begin weight-bearing six weeks after surgery, which reflects the current standard approach. Both groups will begin ankle range-of-motion exercises approximately two weeks after surgery. Participants will be followed for 52 weeks. Ankle function, mobility, quality of life, complications, and routine X-ray findings will be assessed during follow-up. The study will also evaluate participant recruitment, adherence to the assigned rehabilitation protocol, and completeness of study data. The results will help determine whether a larger randomized controlled trial should be conducted and may contribute to future rehabilitation recommendations for patients recovering from surgically treated trimalleolar ankle fractures.

Official title: Early Ambulation Safely in Unstable Ankle Fractures (EASY-Ankle): A Pilot Randomized Controlled Single-Center Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-09-08

Completion Date

2028-06-08

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

OTHER

Postoperative Weight-Bearing Rehabilitation Protocol

Participants will be assigned to one of two postoperative rehabilitation protocols following open reduction and internal fixation of an unstable trimalleolar ankle fracture. The Early Weight-Bearing protocol begins weight-bearing as tolerated at 2 weeks after surgery. The Delayed Weight-Bearing protocol begins weight-bearing as tolerated at 6 weeks after surgery. Both groups begin standardized active and passive ankle range-of-motion exercises at 2 weeks postoperatively.

Locations (1)

The Ottawa Hospital

Ottawa, Ontario, Canada