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Search / Trial NCT05729542

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

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Feb 6, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring two different surgical methods for treating a specific type of ankle injury called an acute ankle syndesmosis injury. This injury often occurs alongside ankle fractures and can lead to long-term problems if not treated properly. The trial will compare two standard treatment options: a suture button and a Fibulink implant. Both methods aim to stabilize the ankle, and researchers want to see which one leads to better recovery outcomes, such as less pain, improved movement, and a quicker return to normal activities.

To be eligible for this study, participants must be 18 years or older and have an ankle fracture that requires surgery. They also need to be able to understand the information about the study and provide consent to participate. If someone joins the trial, they will randomly be assigned to receive one of the two treatment options. Throughout the study, researchers will monitor various factors, including pain levels and how well the ankle heals through imaging tests. This trial is important because it seeks to find the best way to ensure optimal recovery for patients with these challenging 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

About University Of California, San Diego

The University of California, San Diego (UCSD) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust focus on translational medicine, UCSD leverages its interdisciplinary approach to explore groundbreaking therapies and interventions across a wide range of medical fields. The university's state-of-the-art facilities and collaboration with top-tier faculty and researchers ensure a comprehensive and ethical framework for conducting clinical trials, ultimately aiming to enhance patient outcomes and contribute to the global body of medical knowledge.

Locations

San Diego, California, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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