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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
High-tensile strength suture syndesmosis repair
High-tensile strength suture syndesmosis repair
University of California, San Diego
San Diego, California, United States
RECRUITINGVisual Analog Scale (VAS) Pain score
VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain
Time frame: 1 year
Foot and Ankle Disability Index
Functional score with a 0-104 with higher scores indicating better function
Time frame: 1 year
Olerud-Molander Ankle Score
Functional Score with a score of 0-100 with higher scores indicating better function
Time frame: 1 year
Number of participants with medical or surgical complications
Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion
Time frame: 1 year
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