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Early weight-bearing and ROM for Ankle Injury

N/A
Waitlist Available
Led By Richard Jenkinson, MD, FRCSC
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

The primary objective of the investigators randomized controlled trial is to determine if early protected weightbearing and ankle range of motion after surgical treatment (open reduction internal fixation - ORIF) for ankle fractures improves the rate of return to work and functional outcome compared to postoperative ankle immobilization in a non-weightbearing cast.

Eligible Conditions
  • Ankle Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Return to work
Secondary outcome measures
Functional outcome and event rate
Return to work and functional outcome

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early weight-bearing and ROMExperimental Treatment1 Intervention
Patients will be placed in a back slab post-operatively. At 2 weeks post op they will have the back slab removed and placed in a boot orthosis. At this time they will be permitted to weight-bear as tolerated and perform limited ankle range of motion exercises. After 6 weeks post op they will start to wean from the boot orthosis.
Group II: Non-weightbearing no ROMActive Control1 Intervention
Patients will be placed in a back slab post-op and will remain non-weight bearing with crutches with no range of motion for a total of 6 weeks. After 6 weeks post-op, they will be placed in a boot orthosis and permitted to weight-bear as tolerated.

Find a Location

Who is running the clinical trial?

University of TorontoLead Sponsor
690 Previous Clinical Trials
1,019,533 Total Patients Enrolled
Canadian Orthopaedic FoundationOTHER
13 Previous Clinical Trials
1,486 Total Patients Enrolled
Künzli SwissSchuhUNKNOWN

Frequently Asked Questions

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Recent research and studies
clinicaltrials.govStudy
Early Weightbearing and Mobilization Versus Non-Weightbearing and Mobilization in Unstable Ankle Fractures
2010. "Early Weightbearing and Mobilization Versus Non-Weightbearing and Mobilization in Unstable Ankle Fractures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01196338.
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