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

February 5, 2026 updated by: William Kent, University of California, San Diego

Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92093
        • Recruiting
        • University of California, San Diego
        • Contact:
        • Principal Investigator:
          • William Kent, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arthrex Tightrope
Syndesmosis fixation performed with ARthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system.
Device: Arthrex Tightrope
High-tensile strength suture syndesmosis repair
Experimental: Synthes Fibulink
Syndesmosis fixation perforemd with Synthes Fibulink device. This is a high-tension fixation with a screw based anchor system.
Device: Synthes Fibulink
High-tensile strength suture syndesmosis repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) Pain score
Time Frame: 1 year
VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain
1 year
Foot and Ankle Disability Index
Time Frame: 1 year
Functional score with a 0-104 with higher scores indicating better function
1 year
Olerud-Molander Ankle Score
Time Frame: 1 year
Functional Score with a score of 0-100 with higher scores indicating better function
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with medical or surgical complications
Time Frame: 1 year
Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 800669

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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