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

University of California, San Diego · NCT05729542

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
140
US sites recruiting
1
Study start
November 18, 2021
Record last updated
February 10, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Arthrex Tightrope; Synthes Fibulink

Conditions: Ankle Injuries; Syndesmotic Injuries; Ankle Fractures

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of California, San Diego

    San Diego, CA 92093

    Site contact: Dominic Baun, MS · 858-534-8268 · jbaun@health.ucsd.edu

Study contacts (from the official record)

  • Dominic Baun, MS · 858-534-8268 · jbaun@health.ucsd.edu
  • William Kent, MD · 619-543-2694 · wkent@health.ucsd.edu
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Comparing Clinical Outcomes of Suture Button Versus Fibulink… (NCT05729542) | Bored Studies