Recruiting

Suture Button vs. Fibulink

Sponsor:

UCLA

Code:

NCT05729542

Conditions

Ankle Injuries

Syndesmotic Injuries

Ankle Fractures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Arthrex Tightrope

Synthes Fibulink

Study Details

Brief 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.

Conditions

Ankle Injuries

Syndesmotic Injuries

Ankle Fractures

Study ID

NCT05729542

Start date

Nov 18, 2021

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arthrex Tightrope

Syndesmosis fixation performed with ARthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system.

experimental: Synthes Fibulink

Syndesmosis fixation perforemd with Synthes Fibulink device. This is a high-tension fixation with a screw based anchor system.

Interventions

Arthrex Tightrope

High-tensile strength suture syndesmosis repair

Synthes Fibulink

High-tensile strength suture syndesmosis repair

Primary outcome measure

  • Visual Analog Scale (VAS) Pain score [ Time Frame: 1 year ]
  • Foot and Ankle Disability Index [ Time Frame: 1 year ]
  • Olerud-Molander Ankle Score [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Dominic Baun, MS

858-534-8268jbaun@health.ucsd.edu

William Kent, MD

619-543-2694wkent@health.ucsd.edu

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92093

Contacts

Dominic Baun, MS

858-534-8268jbaun@health.ucsd.edu

Principal Investigator:

William Kent, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-02-10.