Trimalleolar Ankle FractureEASY-AnkleNCT07811804
Early Ambulation Safely in Unstable Ankle Fractures (EASY-Ankle)
A study testing Postoperative Weight-Bearing Rehabilitation Protocol in people with Trimalleolar Ankle Fracture and Unstable Trimalleolar Ankle Fracture, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trimalleolar Ankle Fracture, Unstable Trimalleolar Ankle Fracture
- What is being tested?
- Postoperative Weight-Bearing Rehabilitation Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 8 Sep 2026to 8 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maryam Clinical Research Coordinator contact
Canada1 site
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
Hoda Clinical Research Coordinator, 613-737-8899 ext. 1400, hghaziasgar@ohri.ca
Maryam Clinical Research Coordinator, marleclerc@ohri.ca
About this study
Official title: 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.
Read more
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.
- Being tested
- Postoperative Weight-Bearing Rehabilitation Protocol
- Keywords
- Early Weight-Bearing, Delayed Weight-Bearing, Trimalleolar Fracture, ORIF, Weight-Bearing Rehabilitation
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Weight-Bearing Rehabilitation ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Postoperative Weight-Bearing Rehabilitation Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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%.
Measured: 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%.
Measured: 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.
Measured: 12 weeks after surgery
Secondary outcomes (6)
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.
Measured: 6, 12, 26, and 52 weeks after surgery
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.
Measured: 6, 12, 26, and 52 weeks after surgery
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.
Measured: 6, 12, 26, and 52 weeks after surgery
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).
Measured: 6, 12, 26, and 52 weeks after surgery
Incidence of Postoperative Complications
The number and proportion of participants experiencing postoperative complications will be recorded. Complications include fracture displacement or loss of reduction, non-union, malunion, infection, symptomatic deep vein thrombosis, pulmonary embolism, and unplanned re-operation.
Measured: From randomization through 52 weeks after surgery
Incidence of Radiological Loss of Reduction
Routine postoperative radiographs will be reviewed for loss of reduction. The protocol defines relevant findings as talar subluxation greater than 2 mm, excessive talar tilt greater than 2 degrees, or tibiofibular clear space of at least 5 mm.
Measured: 2, 6, 12, 26, and 52 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start8 Sep 2026 (estimated)
- Primary completion8 Sep 2027 (estimated)
- Study completion8 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trimalleolar Ankle FractureStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradley Meulenkamp, MD, MSc, FRCSC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811804
- Sponsor's protocol ID
- 20260355-01H
- Acronym
- EASY-Ankle
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Ambulation Safely in Unstable Ankle Fractures (EASY-Ankle): A Pilot Randomized Controlled Single-Center Trial
- ClinicalTrials.gov ID
- NCT07811804
- Acronym / sponsor ID
- EASY-Ankle / 20260355-01H
- Keywords
- Early Weight-Bearing, Delayed Weight-Bearing, Trimalleolar Fracture, ORIF, Weight-Bearing Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 8 Sep 2026 (estimated)
- Primary completion
- 8 Sep 2027 (estimated)
- Study completion
- 8 Jun 2028 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early Weight-Bearing | Experimental | Other: Postoperative Weight-Bearing Rehabilitation ProtocolParticipants 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. |
| Delayed Weight-Bearing | Active comparator | Other: Postoperative Weight-Bearing Rehabilitation ProtocolParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative Weight-Bearing Rehabilitation ProtocolParticipants 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. | Other | Delayed Weight-Bearing, Early Weight-Bearing |
Primary outcome
Participant Recruitment Rate
Time frame: Throughout the 12-month recruitment period
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%.
Percentage of Participants Adherent to the Assigned Weight-Bearing Protocol
Time frame: From randomization through 6 weeks after surgery
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%.
Completeness of Primary Outcome Data
Time frame: Through 52 weeks after surgery
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%.
Olerud and Molander Ankle Score at 3 Months
Time frame: 12 weeks after surgery
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.
6 secondary outcomes
Change in Olerud and Molander Ankle Score
Time frame: 6, 12, 26, and 52 weeks after surgery
Foot and Ankle Ability Measure Score
Time frame: 6, 12, 26, and 52 weeks after surgery
EuroQol 5-Dimension 5-Level Score
Time frame: 6, 12, 26, and 52 weeks after surgery
Visual Analog Scale Score
Time frame: 6, 12, 26, and 52 weeks after surgery
Incidence of Postoperative Complications
Time frame: From randomization through 52 weeks after surgery
Incidence of Radiological Loss of Reduction
Time frame: 2, 6, 12, 26, and 52 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maryam Clinical Research Coordinator contact
Bradley Meulenkamp, MD, MSc, FRCSC principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative Weight-Bearing Rehabilitation Protocol in people with Trimalleolar Ankle Fracture and Unstable Trimalleolar Ankle Fracture, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hoda Clinical Research Coordinator (613-737-8899 ext. 14300, hghaziasgar@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment Rate (time frame: Throughout the 12-month recruitment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.