Comparing two surgical methods for ankle syndesmosis injuries
Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
This study is testing which of two surgical methods for fixing ankle injuries works better in helping patients recover and feel less pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT05729542 on ClinicalTrials.gov |
What this trial studies
This project is a randomized controlled trial that aims to compare the clinical outcomes of two surgical fixation methods, suture button and Fibulink implant, for patients with acute ankle syndesmosis injuries. Eligible participants, aged 18 and older, will be randomly assigned to one of the two treatment groups after providing consent. The study will evaluate various outcome measures, including pain levels, range of motion, and time to return to work, as well as radiographic assessments to determine the effectiveness of each fixation method. The goal is to identify which method provides better clinical outcomes for patients undergoing surgery for these injuries.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with an ankle fracture that includes a syndesmotic injury requiring surgical intervention.
Not a fit: Patients with severe systemic diseases, those who prefer a specific implant, or those who refuse randomization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery times for patients with ankle syndesmosis injuries.
How similar studies have performed: Other studies have explored various fixation methods for ankle syndesmosis injuries, but this specific comparison of suture button versus Fibulink is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Diego, California
- University of California, San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Dominic Baun, MS
- Email: jbaun@health.ucsd.edu
- Phone: 858-534-8268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.