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NCT05729542NARecruitingAccepts Healthy Volunteers

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

University of California, San Diego

Start Date

11/18/2021

Completion Date

12/31/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Arthrex Tightrope

DEVICE

Synthes Fibulink

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Conditions

Ankle InjuriesSyndesmotic InjuriesAnkle Fractures

Locations

University of California, San Diego

San Diego, California 92093

United States