NCT05729542 Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
| NCT ID | NCT05729542 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Ankle Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2021-11-18 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2021-11-18 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Ankle fracture with associated syndesmotic injury requiring surgery * Age 18 years or older * Ability to understand the content of the patient information/informed consent form Exclusion Criteria: * Any not medically managed severe systemic disease * Patient preference for specific implant * Refusal of randomization * Pregnant patients * Prisoners * Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05729542 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ankle Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05729542 currently recruiting?
Yes, NCT05729542 is actively recruiting participants. Contact the research team at jbaun@health.ucsd.edu for enrollment information.
Where is the NCT05729542 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT05729542 clinical trial?
NCT05729542 is sponsored by University of California, San Diego. The trial plans to enroll 140 participants.