About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Any not medically managed severe systemic disease
Patient preference for specific implant
Refusal of randomization
Pregnant patients
Trial design
Parallel
Treatments tested in this trial
Arthrex Tightrope
DeviceHigh-tensile strength suture syndesmosis repair
Synthes Fibulink
DeviceHigh-tensile strength suture syndesmosis repair
Treatment groups
Trial outcomes
Primary outcomes
Visual Analog Scale (VAS) Pain score
VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain
Foot and Ankle Disability Index
Functional score with a 0-104 with higher scores indicating better function
Olerud-Molander Ankle Score
Functional Score with a score of 0-100 with higher scores indicating better function
Secondary outcomes
Number of participants with medical or surgical complications
Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion
Sponsors and contacts
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