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

University of California San Diego

Status: Enrolling

Conditions: Syndesmotic Injuries; Ankle Fractures; Ankle Injuries

Treatments: Device: Synthes Fibulink; Device: Arthrex Tightrope

Study type: Interventional

Funder types: Other

Identifiers

NCT05729542

800669

Details and patient eligibility

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Arthrex Tightrope

Active Comparator group

Description:

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

Treatment:

Device: Arthrex Tightrope

Synthes Fibulink

Experimental group

Description:

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

Treatment:

Device: Synthes Fibulink