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

Launched by UNITED STATES NAVAL MEDICAL CENTER, SAN DIEGO · Nov 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for fixing a specific type of ankle injury called syndesmotic injury, which often occurs alongside ankle fractures. Traditionally, doctors have used screws to fix these injuries, but there can be problems with screws breaking or loosening, leading to the need for more surgeries. This trial is comparing a newer method using a Fibulink device to another method using a suture button, which is a flexible implant that has become more popular due to its advantages.

To participate in the trial, you must be at least 18 years old and have an ankle fracture that needs surgery for a syndesmotic injury. It's important that you understand the information provided about the study. Participants will be randomly assigned to receive either the Fibulink implant or the suture button, and they will be monitored to see how well each method works. This study is currently recruiting participants, and it aims to provide valuable insights into which fixation method might offer better long-term results for patients with these types of injuries.

Gender

ALL

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