RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-11-18
Study Completion:2027-11-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05729542

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ankle fracture with associated syndesmotic injury requiring surgery
  2. * Age 18 years or older
  3. * Ability to understand the content of the patient information/informed consent form
  1. * Any not medically managed severe systemic disease
  2. * Patient preference for specific implant
  3. * Refusal of randomization
  4. * Pregnant patients
  5. * Prisoners
  6. * Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study

Contacts and Locations

Study Contact

Dominic Baun, MS
CONTACT
858-534-8268
jbaun@health.ucsd.edu
William Kent, MD
CONTACT
619-543-2694
wkent@health.ucsd.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-18
Study Completion Date2027-11-18

Study Record Updates

Study Start Date2021-11-18
Study Completion Date2027-11-18

Terms related to this study

Additional Relevant MeSH Terms

  • Ankle Injuries
  • Syndesmotic Injuries
  • Ankle Fractures