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NCT03970603 · ClinicalTrials.gov registry record · NA
Syndesmosis Ankle Study
A NA study, sponsored by Kyle Schweser MD.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT03970603 is a NA study that has completed, run by Kyle Schweser MD. The registered enrollment target is 40 participants.
The verdict
NCT03970603, a NA study, has completed, sponsored by Kyle Schweser MD.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
A debate regarding ankle fracture fixation centers on time to weight bearing. Recent literature has supported immediate weight bearing in surgically stabilized ankle fractures. However, significant variation among orthopaedic surgeons persists, and weight bearing recommendations change when there is a syndesmotic disruption. There is very little literature on time to weight bearing, with most available series casting/immobilizing these injuries for 6 weeks after fixation. There is very little data examining post-operative weight bearing after syndesmotic stabilization, and the majority centers on screw fixation. The minimum time to weight bearing after an ankle fracture with syndesmotic fixation in the literature is 4 weeks, with most focusing on 6 to 12 weeks. Based on biomechanical data regarding suture button techniques, the investigators hypothesize that patients undergoing ankle fracture fixation plus suture button fixation of their syndesmotic disruption will be able to safely bear weight early (2 weeks) after surgery. The investigator's null hypothesis is that there will be no difference between early weight bearing (2 weeks), and late weight bearing (6 weeks) in terms of outcome, hardware failure, loss of reduction, and return to work. Adult patients who have an ankle fracture with suspected syndesmotic disruption, requiring a suture button fixation operative intervention will be randomized into early (2 weeks post-surgically) weight-bearing status or delayed weight-bearing status (non-weight-bearing for 6 weeks following fixation). Primary objective: Maintenance of ankle reduction at 1 year follow-up (measured by comparing immediate post-op CT and 1 year time-point CT). Secondary Objectives: Pain scores, surgical experience, work productivity and activity impairment , AAOS foot and ankle scores (2w, 6w, 12w, 6m, 1y), use of assistive devices, range of motion, physical therapy requirement/length of use/compliance, post-operative protocol compliance, post-
Interventions
- OTHER Early Weight-Bearing
- OTHER Delayed/Late Weight-Bearing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-10-15 |
| Est. Completion | 2025-09-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03970603
The ClinicalTrials.gov registry entry for NCT03970603 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kyle Schweser MD, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Early Weight-Bearing is the first listed.
NCT03970603 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03970603 about?
NCT03970603 is a clinical study titled "Syndesmosis Ankle Study". A debate regarding ankle fracture fixation centers on time to weight bearing. Recent literature has supported immediate weight bearing in surgically stabilized ankle fractures. However, significant variation among orthopaedic surgeons persists, and weight bearing recommendations change when there is...
What is the current status of trial NCT03970603?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2019-10-15. Estimated completion is 2025-09-25.
What interventions are being tested in trial NCT03970603?
The interventions under investigation include: Early Weight-Bearing (OTHER), Delayed/Late Weight-Bearing (OTHER).
Who is sponsoring clinical trial NCT03970603?
This trial is sponsored by Kyle Schweser MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
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