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RECRUITING
NCT05626036
NA

Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

Sponsor: United States Naval Medical Center, San Diego

View on ClinicalTrials.gov

Summary

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.

Official title: Randomized Controlled Trial Comparing Clinical Outcomes of Patients Treated Surgically With Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2022-12-01

Completion Date

2024-12

Last Updated

2024-05-06

Healthy Volunteers

No

Interventions

DEVICE

Arthrex Tightrope

High-tensile strength suture syndesmosis repair

DEVICE

Synthes Fibulink

High-tensile strength suture syndesmosis repair

Locations (1)

Naval Medical Center San Diego

San Diego, California, United States