Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
United States Naval Medical Center, San Diego
50 participants
Dec 1, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria6
- 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
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Interventions
High-tensile strength suture syndesmosis repair
High-tensile strength suture syndesmosis repair
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05626036