Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Purpose
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.
Conditions
- Ankle Injuries
- Syndesmotic Injuries
- Ankle Fractures
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Arthrex Tightrope |
Syndesmosis fixation performed with ARthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system. |
|
|
Experimental Synthes Fibulink |
Syndesmosis fixation perforemd with Synthes Fibulink device. This is a high-tension fixation with a screw based anchor system. |
|
Recruiting Locations
San Diego 5391811, California 5332921 92093
More Details
- Status
- Recruiting
- Sponsor
- University of California, San Diego