Early Ambulation for Ankle Fracture
(EASY-Ankle Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Bradley Meulenkamp, MD, MSc, FRCSC
Principal Investigator
Ottawa Hospital Research Institute
Are You a Good Fit for This Trial?
This trial is for adults who have had surgery to fix an unstable trimalleolar ankle fracture. Participants should be able to follow rehabilitation instructions and attend follow-up visits. People with other major injuries or health issues that could affect recovery may not be eligible.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Postoperative Weight-Bearing Rehabilitation Protocol
Trial Overview
The study compares two rehab approaches after ankle fracture surgery: one group starts putting weight on their ankle at 2 weeks, while the other waits until 6 weeks (the usual practice). Both groups do movement exercises from week 2. Patients are randomly assigned to each group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will remain non-weight-bearing for the first 2 weeks after surgery. Beginning 2 weeks postoperatively, participants will start weight-bearing as tolerated on the affected leg, using walking aids as needed. Participants will also begin standardized active and passive ankle range-of-motion exercises at 2 weeks after surgery.
Participants will remain non-weight-bearing on the operated leg for 6 weeks after surgery, using walking aids as needed. After 6 weeks, participants may begin weight-bearing as tolerated. Participants will begin the same standardized active and passive ankle range-of-motion exercises at 2 weeks after surgery.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Hospital Research Institute
Lead Sponsor
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