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NCT04972578 · ClinicalTrials.gov registry record · NA
Comparison of Gait in Syndesmosis Injuries Treated With Screw Fixation vs Suture Button
A NA study, sponsored by University of Nebraska.
- Terminated
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT04972578: Clinical Trial NA study, sponsored by University of Nebraska.
NCT04972578 is a NA study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04972578, a NA study, was terminated before completion, sponsored by University of Nebraska.
- TERMINATED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
Injuries to the distal tibiofibular syndesmosis are common and occur in an estimated 25% of all rotational ankle fractures. Anatomic reduction of the syndesmosis has been associated with improved functional outcome as well as decreased rates of posttraumatic arthritis. Both screw fixation and suture fixation have become accepted standards of care for treatment of syndesmotic injuries. Recent literature would suggest trends favoring suture fixation over screw fixation with improved quality of syndesmotic reduction, postoperative range of motion, and improved maintenance of syndesmotic reduction. However, the evidence remains heterogeneous, and patient reported outcomes have failed to show a superiority of one method over the other. Additionally, there have been no studies that demonstrate objective gait outcomes comparing screw versus suture fixation for syndesmotic injuries.
Primary Outcome
Step length will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Interventions
- DEVICE Suture Button vs Screw Fixation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2026-01-09 |
| Phase | NA |
Why NCT04972578 stopped before completion
NCT04972578 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Suture Button vs Screw Fixation is the first listed.
NCT04972578 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04972578 about?
NCT04972578 is a clinical study titled "Comparison of Gait in Syndesmosis Injuries Treated With Screw Fixation vs Suture Button". Injuries to the distal tibiofibular syndesmosis are common and occur in an estimated 25% of all rotational ankle fractures. Anatomic reduction of the syndesmosis has been associated with improved functional outcome as well as decreased rates of posttraumatic arthritis. Both screw fixation and suture...
What is the current status of trial NCT04972578?
This trial is currently terminated. It is a NA study. The enrollment target is 21 participants. The study started on 2021-10-01. Estimated completion is 2026-01-09.
What interventions are being tested in trial NCT04972578?
The interventions under investigation include: Suture Button vs Screw Fixation (DEVICE).
Who is sponsoring clinical trial NCT04972578?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04972578's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 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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