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Comparing Clinical Outcomes of 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
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full eligibility 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
About the study
This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an acute ankle syndesmosis injury requiring surgery. Patients who consent to study participation will be randomized to receive one of two standard of care procedures - either a suture button or Fibulink implant. Outcome measures, including the Olerud-Molander and American Orthopaedic Foot and Ankle Society scores, pain, range of motion, time to return to work, and radiographic evaluation will be collected for each participant. Given the potential degenerative changes and poor radiographic and clinical outcomes with inadequate repair of the syndesmosis, it is imperative to evaluate existing and emerging methods of fixation for patients with acute ankle fractures with syndesmosis injuries.
What is being tested
- Arthrex Tightrope (device)
- Synthes Fibulink (device)
Sponsor: University of California, San Diego · Participants: 140 · Started: Nov 18, 2021
Contact the study team
- Dominic Baun, MS · Phone: 858-534-8268
- William Kent, MD · Phone: 619-543-2694
Official record on ClinicalTrials.gov — NCT05729542
Locations in the U.S.
| California | University of California, San Diego, San Diego |
Conditions
From ClinicalTrials.gov, data retrieved Oct 3, 2026. Each study sets its own eligibility; the study team decides who can join.