Syndesmotic Injuries Clinical Trial
Official title:
Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Ankle fractures are a common injury with potentially significant morbidity. Syndesmosis injury occurs in 10% to 13% of ankle fractures and poses a greater risk to long-term outcomes for patients. The gold standard for syndesmosis fixation has traditionally been screw fixation. However, issues with screw fixation include screw breakage, screw loosening, reoperation, and malreduction. Due to growing concerns with static screw fixation, implants based on the flexible suture button design, such as the TightRope system, gained traction. The Fibulink Syndesmosis Repair System, a relatively new design that became clinically available in 2017, has showed promising results. To our knowledge, there is no study that directly compares outcomes with the Fibulink implant to suture button implants.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Naval Medical Center San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
United States Naval Medical Center, San Diego |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale (VAS) pain score | VAS pain score is rated from 0-10 with 0 being no pain and 10 being the worst pain possible. | 1 year | |
Primary | Foot and Ankle Disability Index | Functional score with a score of 0-104 with higher scores indicating better function. | 1 year | |
Primary | Olerud-Molander Ankle Score | Functional score with a score of 0-100 with higher scores indicating better function | 1 year | |
Secondary | 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 |
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