Early vs Delayed Weightbearing After Surgical Fixation of Unstable Ankle Fractures With Syndesmosis Disruption
NCT05587842 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2026-05-22
Summary
No study has prospectively compared a traditional post-operative non-weightbearing protocol versus early post-operative weightbearing as tolerated for unstable ankle injuries after surgical fixation of the syndesmosis. This prospective study will attempt to determine if early weightbearing can improve functional outcomes, result in a quicker return to work, and monitor differences in rates of adverse events. It will exclude the most severe ankle injuries and patients with excluding comorbidities.
Conditions
- Unstable Ankle Fractures With Syndesmotic Disruption
Interventions
- PROCEDURE
-
Early Weightbearing management post operation
Subjects will be instructed to be weightbearing, as tolerated, on their ankle starting at two weeks post operation.
- PROCEDURE
-
Delayed Weightbearing management post operation (Traditional)
Subjects will be instructed to be non-weightbearing on their ankle until at least 6 weeks. After 6 weeks, the subject will be instructed to be weightbearing as tolerated.
Sponsors & Collaborators
-
University of Arizona
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-10
- Primary Completion
- 2027-03-31
- Completion
- 2027-03-31
Countries
- United States
Study Locations
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