Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Synd… (NCT05626036) | Clinical Trial Compass
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Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
United States50 participantsStarted 2022-12-01
Plain-language summary
Ankle fractures are a common injury with potentially significant morbidity. Syndesmosis injury occurs in 10% to 13% of ankle fractures and poses a greater risk to long-term outcomes for patients.
The gold standard for syndesmosis fixation has traditionally been screw fixation. However, issues with screw fixation include screw breakage, screw loosening, reoperation, and malreduction. Due to growing concerns with static screw fixation, implants based on the flexible suture button design, such as the TightRope system, gained traction.
The Fibulink Syndesmosis Repair System, a relatively new design that became clinically available in 2017, has showed promising results.
To our knowledge, there is no study that directly compares outcomes with the Fibulink implant to suture button implants.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analog Scale (VAS) pain score
Timeframe: 1 year
2
Foot and Ankle Disability Index
Timeframe: 1 year
3
Olerud-Molander Ankle Score
Timeframe: 1 year
Trial details
NCT IDNCT05626036
SponsorUnited States Naval Medical Center, San Diego