An interventional study of Postoperative Weight-Bearing Rehabilitation Protocol in Trimalleolar Ankle Fracture and Unstable Trimalleolar Ankle Fracture, sponsored by Ottawa Hospital Research Institute. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Ottawa Hospital Research Institute · Not applicable, Interventional, and Treatment
Among 13 studies in Ankle Fractures with a site in Canada — 3 open to participants now, 3 under way, none of them phase 3. Ankle Fractures · Canada.
Among the 13 studies in Ankle Fractures with a site in Canada, this one is the only one that started in 2026, is one of 8 with no phase, and was the 13th registered.
202 studies on the registry are indexed under Ankle Fractures; 44 are open to participants now.
Browse Ankle Fractures studies →3 of the 13 studies in Ankle Fractures with a site in Canada are open now. Recruiting first, the newest first:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Sites in Canada
Nova Scotia Health Authority · Sites in Canada
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 31 Ankle Fractures studies recruiting now, 14 (45%) set no upper age limit and 12 (39%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 50 is below the median of 90 across 150 interventional studies indexed under Ankle Fractures.
Median enrollment 110 across the 9 interventional studies, 161 across the 4 observational. Of the 7 that completed or were terminated, 3 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 13 have an industry lead sponsor. The 10 most frequent:
Ottawa Hospital Research Institute is the lead sponsor of 547 studies on the registry; 99 are open to participants now.
Ottawa Hospital Research Institute has 3 studies filed under Ankle Fractures — fewer than ten, so there is no comparison to draw.
2 of the studies in Ankle Fractures with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05131321London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sFRAME Study (Frailty-Related Ankle Fracture Management and Evaluation) | 2026-12 |
| NCT07811804Ottawa Hospital Research InstituteEarly Ambulation Safely in Unstable Ankle Fractures (EASY-Ankle) | 2027-09-08 |
Among the 13 studies in Ankle Fractures with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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 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%.
Time frame: 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%.
Time frame: 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.
Time frame: 12 weeks after surgery
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 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 2, 6, 12, 26, and 52 weeks after surgery
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 69 non-industry interventional studies with no phase under Ankle Fractures, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 61. This study's planned 12 months is below that.
Counting every sponsor, half of 72 studies reached it within 45 months; a quarter within 23 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Ottawa Hospital Research Institute →