Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

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.

Inclusion Criteria:Ankle fracture with associated syndesmotic injury requiring surgeryAge 18 years or olderAbility to understand the content of the patient information/Informed consent formExclusion Criteria:Any not medically managed severe systemic diseasePatient preference for specific implantRefusal of randomizationPregnant patientsPrisonersParticipation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study