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

Ankle Fractures Clinical Trial

Official title:

Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05729542
• Other study ID #: 800669
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2021
• Est. completion date: November 18, 2026

Study information

• Verified date: March 2023
• Source: University of California, San Diego
• Contact: Dominic Baun, MS
• Phone: 858-534-8268
• Email: jbaun[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: November 18, 2026
• Est. primary completion date: November 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Ankle Injuries
• Syndesmotic Injuries
• Wounds and Injuries

Intervention

Device:
• Arthrex Tightrope
High-tensile strength suture syndesmosis repair
• Synthes Fibulink
High-tensile strength suture syndesmosis repair

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS) Pain score	VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain	1 year
Primary	Foot and Ankle Disability Index	Functional score with a 0-104 with higher scores indicating better function	1 year
Primary	Olerud-Molander Ankle Score	Functional Score with a score of 0-100 with higher scores indicating better function	1 year
Secondary	Number of participants with medical or surgical complications	Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion	1 year