Randomized Comparison of Arthrex Tightrope versus Synthes Fibulink Devices for Surgical Repair of Acute Ankle Syndesmosis Injuries in Adults

What this Trial Is About

Researchers are conducting a randomized controlled study to compare two surgical devices used for repairing acute ankle syndesmosis injuries in adults. The study focuses on patients aged 18 years or older who have an ankle fracture with an associated syndesmotic injury requiring surgery. The goal is to evaluate and compare the outcomes of two standard surgical fixation methods to better understand their effectiveness in treating these injuries and preventing degenerative changes. Participants will be randomly assigned to receive one of two surgical devices for syndesmosis fixation the Arthrex Tightrope, which uses a high-tensile strength suture with a button-based anchor system, or the Synthes Fibulink, which uses a high-tensile strength suture with a screw-based anchor system. Both devices are considered standard of care procedures. The study includes a one-year follow-up period to assess recovery and outcomes. During the study, participants will be monitored through various assessments, including pain measurement using the Visual Analog Scale VAS, disability indices like the Foot and Ankle Disability Index and the Olerud-Molander Ankle Score, as well as radiographic evaluations. Researchers will also track complications related to medical or surgical issues. The total duration of participation includes surgery and follow-up evaluations over one year to measure recovery and functional outcomes.

Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries