Comparing two methods for fixing ankle syndesmosis injuries
Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
NA · United States Naval Medical Center, San Diego · NCT05626036
This study is testing which of two surgical methods, a suture button or the Fibulink system, works better for fixing ankle injuries and helping patients feel better after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | United States Naval Medical Center, San Diego (fed) |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT05626036 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two fixation methods, the suture button and the Fibulink system, for treating acute syndesmosis injuries associated with ankle fractures. The study will involve patients who require surgical intervention for their injuries and will assess outcomes such as pain, stability, and long-term joint health. By evaluating these two approaches, the trial seeks to determine which method provides better clinical outcomes and reduces the risk of complications. Participants will be randomly assigned to receive one of the two fixation methods.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have an ankle fracture with an associated 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 treatment options for patients with ankle syndesmosis injuries, potentially reducing complications and enhancing recovery.
How similar studies have performed: While there have been studies on various fixation methods for syndesmosis injuries, this trial is novel as it directly compares the Fibulink system to the established suture button approach.
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
- Naval Medical Center San Diego — San Diego, California, United States (RECRUITING)
Study contacts
- Principal investigator: Benjamin Wheatley — NMCSD
- Study coordinator: Ashley Hughey
- Email: ashley.e.hughey.ctr@health.mil
- Phone: 619-532-9535
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.
Conditions: Syndesmotic Injuries, syndesmosis, clinical outcomes, ankle fracture