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

NCT ID: NCT05729542

Last Updated: 2026-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-18

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ankle Injuries Syndesmotic Injuries Ankle Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Arthrex Tightrope

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

Group Type ACTIVE_COMPARATOR

Arthrex Tightrope

Intervention Type DEVICE

High-tensile strength suture syndesmosis repair

Synthes Fibulink

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

Group Type EXPERIMENTAL

Synthes Fibulink

Intervention Type DEVICE

High-tensile strength suture syndesmosis repair

Interventions

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Arthrex Tightrope

High-tensile strength suture syndesmosis repair

Intervention Type DEVICE

Synthes Fibulink

High-tensile strength suture syndesmosis repair

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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William Kent

Assistant Professor of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, San Diego

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dominic Baun, MS

Role: CONTACT

858-534-8268

William Kent, MD

Role: CONTACT

619-543-2694

Facility Contacts

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Dominic Baun, MS

Role: primary

858-534-8268

Other Identifiers

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800669

Identifier Type: -

Identifier Source: org_study_id

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