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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego

About this trial

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

Qualifiers

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

Disqualifiers

Any not medically managed severe systemic disease

Patient preference for specific implant

Refusal of randomization

Pregnant patients

Trial design

Treatments tested in this trial

  • Arthrex Tightrope
  • Synthes Fibulink

Treatment groups

140 Participants
are divided into 2 treatment groups