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

NCT05729542 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-02-10

No results posted yet for this study

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

Interventions

DEVICE

Arthrex Tightrope

High-tensile strength suture syndesmosis repair

DEVICE

Synthes Fibulink

High-tensile strength suture syndesmosis repair

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05729542 on ClinicalTrials.gov