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

NCT07811804 | Not Yet Recruiting DMC

• 1 other identifier: 20260355-01H
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trimalleolar Ankle Fracture; Unstable Trimalleolar Ankle Fracture

Keywords

Early Weight-Bearing; Delayed Weight-Bearing; Trimalleolar Fracture; ORIF; Weight-Bearing Rehabilitation

Outcome Measures

Primary Outcomes (4)

• Participant Recruitment Rate

  Feasibility of recruitment will be assessed using the number and proportion of screened patients who meet the eligibility criteria and the proportion of eligible patients who consent to participate. The protocol identifies an eligibility-rate target of at least 60% and a consent-rate target of at least 30%.

  Throughout the 12-month recruitment period

• Percentage of Participants Adherent to the Assigned Weight-Bearing Protocol

  Participant adherence will be assessed using self-reported compliance with the assigned early or delayed weight-bearing protocol. Measures will include intervention compliance and crossover between treatment groups. The protocol specifies an intervention-compliance target of at least 90% and a crossover-rate target of no more than 5%.

  From randomization through 6 weeks after surgery

• Completeness of Primary Outcome Data

  Feasibility of data collection will be assessed using the proportion of participants with complete and valid Olerud and Molander Ankle Score data and the proportion lost to follow-up. The protocol specifies a valid primary-outcome-data target of at least 80% and an attrition or loss-to-follow-up target of no more than 15%.

  Through 52 weeks after surgery

• Olerud and Molander Ankle Score at 3 Months

  Ankle function will be measured using the Olerud and Molander Ankle Score (OMAS). The OMAS ranges from 0 to 100 points, with higher scores indicating better ankle function and fewer symptoms. Scores will be compared between the Early Weight-Bearing and Delayed Weight-Bearing groups. The score assesses ankle symptoms and the ability to perform activities such as walking, running, jumping, and stair use. The protocol specifies a non-inferiority margin of -8 points.

  12 weeks after surgery

Secondary Outcomes (6)

• Change in Olerud and Molander Ankle Score

  6, 12, 26, and 52 weeks after surgery

• Foot and Ankle Ability Measure Score

  6, 12, 26, and 52 weeks after surgery

• EuroQol 5-Dimension 5-Level Score

  6, 12, 26, and 52 weeks after surgery

• Visual Analog Scale Score

  6, 12, 26, and 52 weeks after surgery

• Incidence of Postoperative Complications

  From randomization through 52 weeks after surgery

Study Arms (2)

Early Weight-Bearing

EXPERIMENTAL

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.

Other: Postoperative Weight-Bearing Rehabilitation Protocol

Delayed Weight-Bearing

ACTIVE COMPARATOR

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.

Other: Postoperative Weight-Bearing Rehabilitation Protocol

Interventions

Postoperative Weight-Bearing Rehabilitation Protocol OTHER

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.

Delayed Weight-Bearing; Early Weight-Bearing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Officials

• Bradley Meulenkamp, MD, MSc, FRCSC

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hoda Clinical Research Coordinator

CONTACT

613-737-8899; hghaziasgar@ohri.ca

Maryam Clinical Research Coordinator

CONTACT

marleclerc@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and intervention providers cannot be blinded because of the nature of the assigned weight-bearing instructions. Outcome assessments will be conducted by personnel blinded to treatment allocation to the best of the study team's ability.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized in a 1:1 ratio to one of two parallel postoperative rehabilitation groups: early weight-bearing beginning 2 weeks after surgery or delayed weight-bearing beginning 6 weeks after surgery.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: September 10, 2026
• Study Start: September 8, 2026
• Primary Completion (Estimated): September 8, 2027
• Study Completion (Estimated): June 8, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

CA (1)