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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 is a NA study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 21 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04972578
The ClinicalTrials.gov registry entry for NCT04972578 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Suture Button vs Screw Fixation is the first listed.
NCT04972578 reports 0 study locations.
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.
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