Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Syndesmotic Injuries
About this trial
This is an interventional treatment trial for Syndesmotic Injuries focused on measuring syndesmosis, clinical outcomes, ankle fracture
Eligibility Criteria
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
Sites / Locations
- Naval Medical Center San Diego
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arthrex Tightrope
Synthes Fibulink
Syndesmosis fixation performed with Arthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system.
Syndesmosis fixation performed with Synthes Fibulink device. This is a high-tension suture fixation with a screw based anchor system.