Actively Recruiting
Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Led by University of California, San Diego · Updated on 2026-02-10
140
Participants Needed
1
Research Sites
319 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Diego
San Diego, California, United States, 92093
Actively Recruiting
Research Team
D
Dominic Baun, MS
CONTACT
W
William Kent, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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