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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Ankle Injuries
Intervention / Treatment

-

Contacts and Locations

San Diego

University of California, San Diego, San Diego, California, United States, 92093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of California, San Diego,

Study Record Dates

2027-11-18