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Comparing Suture Button vs. Fibulink for Ankle Syndesmosis Injuries

This study is looking for people who have had an ankle fracture that also involves a syndesmotic injury (a specific type of ligament injury in the ankle) and need surgery. Researchers want to compare two different devices used to fix these injuries: the Arthrex Tightrope and the Synthes Fibulink. Both are high-strength sutures designed to repair the syndesmosis. The goal is to see which device leads to better results, measured by your pain level, how well you can use your foot and ankle, and your overall ankle function one year after surgery. You must be at least 18 years old to participate.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to receive either the Arthrex Tightrope or the Synthes Fibulink device. The study plans to enroll 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year after treatment to assess pain, foot and ankle disability, and ankle function.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05626036

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

UNKNOWN
NAAges 18+InterventionalTreatment
United States Naval Medical Center, San Diego
~50 participants
Updated 2024-05-06 on ClinicalTrials.gov
What's tested:Arthrex TightropeSynthes Fibulink

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Visual Analog Scale (VAS) pain score
Measured over 1 year
+2 more outcomes measured

Conditions

Syndesmotic Injuries

Explore related trials

Ankle FractureSyndesmotic Injuries

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Benjamin Wheatley · PRINCIPAL_INVESTIGATOR · NMCSD

Who to contact

Ashley Hughey
[email protected]
619-532-9535
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Visual Analog Scale (VAS) pain score1 year

    VAS pain score is rated from 0-10 with 0 being no pain and 10 being the worst pain possible.

  • Foot and Ankle Disability Index1 year

    Functional score with a score of 0-104 with higher scores indicating better function.

  • Olerud-Molander Ankle Score1 year

    Functional score with a score of 0-100 with higher scores indicating better function