Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

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

Conditions
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Ankle Injuries, Syndesmotic Injuries, Ankle Fractures

Intervention / Treatment
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* Device: Arthrex Tightrope
* Device: Synthes Fibulink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arthrex Tightrope<br>Syndesmosis fixation performed with ARthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system. | Device: Arthrex Tightrope<br>* High-tensile strength suture syndesmosis repair<br>|
| Experimental: Synthes Fibulink<br>Syndesmosis fixation perforemd with Synthes Fibulink device. This is a high-tension fixation with a screw based anchor system. | Device: Synthes Fibulink<br>* High-tensile strength suture syndesmosis repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Pain score | VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain | 1 year | 
| Foot and Ankle Disability Index | Functional score with a 0-104 with higher scores indicating better function | 1 year | 
| Olerud-Molander Ankle Score | Functional Score with a score of 0-100 with higher scores indicating better function | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with medical or surgical complications | Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion | 1 year |