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

Not Applicable

Recruiting

• Conditions: Ankle Fractures; Ankle Injuries; Syndesmotic Injuries

• Registration Number: NCT05729542
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-18
• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-11-18
• Study Completion: 2027-11-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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