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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: Completed NA study, sponsored by Kyle Schweser MD.
NCT03970603 is a NA study that has completed, run by Kyle Schweser MD. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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-
Primary Outcome
Determined by comparing the 1-year, post-operative CT scan to the immediate post-operative CT scan of the injured ankle
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 |
What the finished NCT03970603 record still lists
NCT03970603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Early Weight-Bearing is the first listed.
NCT03970603 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03970603's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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