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

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

Inclusion Criteria:

• Age 18 years or older.
• Operative fixation of an unstable trimalleolar ankle fracture, with or without a syndesmotic injury requiring fixation.
• Satisfactory anatomical reduction and rigid internal fixation achieved according to established AO principles, including fixation of the posterior malleolus where indicated.
• Surgery performed within 14 days of the injury.
• Able and willing to provide informed consent.

Exclusion Criteria:

• Lack of protective sensation, such as peripheral neuropathy.
• Unable to adhere to trial procedures.
• Bilateral operatively treated ankle fractures.
• Treatment of the index fracture with a hindfoot nail.
• Morbid obesity, defined as body mass index greater than 40.
• Diabetes.
• Neuroarthropathy.