RECRUITING

Randomized Controlled Trial Comparing 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

Ankle fractures are a common injury with potentially significant morbidity. Syndesmosis injury occurs in 10% to 13% of ankle fractures and poses a greater risk to long-term outcomes for patients. The gold standard for syndesmosis fixation has traditionally been screw fixation. However, issues with screw fixation include screw breakage, screw loosening, reoperation, and malreduction. Due to growing concerns with static screw fixation, implants based on the flexible suture button design, such as the TightRope system, gained traction. The Fibulink Syndesmosis Repair System, a relatively new design that became clinically available in 2017, has showed promising results. To our knowledge, there is no study that directly compares outcomes with the Fibulink implant to suture button implants.

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:2022-12-01
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05626036

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:No
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

Ashley Hughey
CONTACT
619-532-9535
ashley.e.hughey.ctr@health.mil

Principal Investigator

Benjamin Wheatley
PRINCIPAL_INVESTIGATOR
NMCSD

Study Locations (Sites)

Naval Medical Center San Diego
San Diego, California, 92134
United States

Collaborators and Investigators

Sponsor: United States Naval Medical Center, San Diego

  • Benjamin Wheatley, PRINCIPAL_INVESTIGATOR, NMCSD

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 Date2022-12-01
Study Completion Date2024-12

Study Record Updates

Study Start Date2022-12-01
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • syndesmosis
  • clinical outcomes
  • ankle fracture

Additional Relevant MeSH Terms

  • Syndesmotic Injuries