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NCT05729542 · ClinicalTrials.gov registry record · NA
Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
A NA study of Ankle Fractures and Syndesmotic Injuries, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- NA
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT05729542: Recruiting NA study of Ankle Fractures and Syndesmotic Injuries, sponsored by University of California, San Diego.
NCT05729542 is a NA study of Ankle Fractures and Syndesmotic Injuries that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 140 participants, below the 242-participant average among 12 other Ankle Fractures trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05729542, a NA study of Ankle Fractures and Syndesmotic Injuries, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study Summary
This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an acute ankle syndesmosis injury requiring surgery. Patients who consent to study participation will be randomized to receive one of two standard of care procedures - either a suture button or Fibulink implant. Outcome measures, including the Olerud-Molander and American Orthopaedic Foot and Ankle Society scores, pain, range of motion, time to return to work, and radiographic evaluation will be collected for each participant. Given the potential degenerative changes and poor radiographic and clinical outcomes with inadequate repair of the syndesmosis, it is imperative to evaluate existing and emerging methods of fixation for patients with acute ankle fractures with syndesmosis injuries.
Primary Outcome
VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain
Conditions Studied
Interventions
- DEVICE Arthrex Tightrope
- DEVICE Synthes Fibulink
Study Locations (1)
California
- University of California, San Diego - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2021-11-18 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
What NCT05729542 shows while recruiting
NCT05729542 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 242-participant average among 12 other Ankle Fractures trials with a reported enrollment target (42% lower).
The record links to 3 conditions, with Ankle Fractures appearing as the primary indexed condition, and to 2 interventions - of which Arthrex Tightrope is the first listed.
NCT05729542 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05729542 about?
NCT05729542 is a clinical study titled "Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries". This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an acute ankle syndesmosis injury requiring surgery. Patients who consent to study participation will be randomized to receive one...
What is the current status of trial NCT05729542?
This trial is currently recruiting. It is a NA study. The enrollment target is 140 participants. The study started on 2021-11-18. Estimated completion is 2027-12-31.
What conditions does trial NCT05729542 study?
This clinical trial studies the following conditions: Ankle Fractures, Syndesmotic Injuries, Ankle Injuries.
What interventions are being tested in trial NCT05729542?
The interventions under investigation include: Arthrex Tightrope (DEVICE), Synthes Fibulink (DEVICE).
Who is sponsoring clinical trial NCT05729542?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05729542 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05729542's enrollment target sits among peer trials
140 5th of 12 higher than 8 of 12 other Ankle Fractures trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ankle Fractures 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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