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NCT04972578
Comparison of Gait in Syndesmosis Injuries Treated With Screw Fixation vs Suture Button
NA trial testing Suture Button vs Screw Fixation in Acute Disruption of Ankle Syndesmosis in 21 participants. Terminated before completion.
8 January 2026
Quick facts
| Lead sponsor | University of Nebraska |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 1 October 2021 |
| Primary completion | 8 January 2026 |
| Estimated completion | 9 January 2026 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Suture Button vs Screw Fixation
Conditions studied
- Acute Disruption of Ankle Syndesmosis — all drugs for Acute Disruption of Ankle Syndesmosis →
Sponsor
University of Nebraska
Who can join
19 and older, any sex, with Acute Disruption of Ankle Syndesmosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT04972578
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04972578 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Nebraska
- Last refreshed: 13 January 2026
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