Comparing two surgical methods for ankle syndesmosis injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project is a randomized controlled trial that aims to compare the clinical outcomes of two surgical fixation methods, suture button and Fibulink implant, for patients with acute ankle syndesmosis injuries. Eligible participants, aged 18 and older, will be randomly assigned to one of the two treatment groups after providing consent. The study will evaluate various outcome measures, including pain levels, range of motion, and time to return to work, as well as radiographic assessments to determine the effectiveness of each fixation method. The goal is to identify which method provides better clinical outcomes for patients undergoing surgery for these injuries.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, San Diego
  San Diego, California, United States Recruiting

Study contacts

• Study coordinator: Dominic Baun, MS
• Email: jbaun@health.ucsd.edu
• Phone: 858-534-8268

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ankle Muscle Power Program to Help Return to Duty After an Ankle Fracture

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• Improving balance and control in athletes with chronic ankle instability

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  Recruiting at 2 sites Yeditepe University · Istanbul and 1 other locations · NCT06898554

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.