Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California
Dates
study started
completion around
Principal Investigator
by William Kent, MD
Headshot of William Kent
William Kent

Description

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.

Official Title

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

Keywords

Ankle Injuries, Syndesmotic Injuries, Ankle Fractures, Wounds and Injuries, Arthrex Tightrope, Synthes Fibulink

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • University of California, San Diego accepting new patients
    San Diego California 92093 United States

Lead Scientist at UCSD

  • William Kent, MD
    Associate Clinical Professor, Orthopedic Surgery, Vc-health Sciences-schools. Authored (or co-authored) 38 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05729542
Study Type
Interventional
Participants
Expecting 140 study participants
Last Updated