Actively Recruiting
Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Led by United States Naval Medical Center, San Diego · Updated on 2024-05-06
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Naval Medical Center San Diego
San Diego, California, United States, 92134
Actively Recruiting
Research Team
A
Ashley Hughey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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