Ankle Fractures, Ankle Injuries, Syndesmotic Injuries
Conditions
Brief 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.
Interventions
DEVICEArthrex Tightrope
High-tensile strength suture syndesmosis repair
DEVICESynthes Fibulink
High-tensile strength suture syndesmosis repair
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Pain score | 1 year | VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain |
| Foot and Ankle Disability Index | 1 year | Functional score with a 0-104 with higher scores indicating better function |
| Olerud-Molander Ankle Score | 1 year | Functional Score with a score of 0-100 with higher scores indicating better function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with medical or surgical complications | 1 year | Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion |
Countries
United States
Contacts
CONTACTDominic Baun, MS
CONTACTWilliam Kent, MD
Outcome results
None listed