Early Ambulation Safely in Unstable Ankle Fractures (EASY-Ankle)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Postoperative Weight-Bearing Rehabilitation Protocol
Other interventionParticipants 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Early Weight-BearingExperimental treatment 1 intervention
Group B: Delayed Weight-BearingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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%.
Time frame
Throughout the 12-month recruitment period2
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%.
Time frame
From randomization through 6 weeks after surgery3
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%.
Time frame
Through 52 weeks after surgery4
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.
Time frame
12 weeks after surgerySecondary outcomes
1
Change in Olerud and Molander Ankle Score
Ankle function, pain, and ability to perform daily activities will be assessed using the Olerud and Molander Ankle Score. Scores range from 0 to 100, with higher scores indicating better ankle function and fewer symptoms.
Time frame
6, 12, 26, and 52 weeks after surgery2
Foot and Ankle Ability Measure Score
Foot and ankle function during daily and more demanding activities will be assessed using the Foot and Ankle Ability Measure. Scores are expressed as a percentage from 0% to 100%, with higher scores indicating better function.
Time frame
6, 12, 26, and 52 weeks after surgery3
EuroQol 5-Dimension 5-Level Score
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire. The questionnaire assesses five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated on 5 levels; from 1 indicating no problems to 5 indicating extreme problems or inability to perform the activity. Higher levels indicate greater impairment.
Time frame
6, 12, 26, and 52 weeks after surgery4
Visual Analog Scale Score
Participants' self-reported health status or pain will be assessed using a visual analog scale (VAS) . Pain will be assessed using a 10 cm VAS ranging from 0 cm (no pain) to 10 cm (pain as bad as it could possibly be).
Time frame
6, 12, 26, and 52 weeks after surgerySponsors and contacts
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Source ClinicalTrials.gov
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