Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
NCT ID: NCT05729542
Last Updated: 2026-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2021-11-18
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arthrex Tightrope
Syndesmosis fixation performed with ARthrex Tightrope device. This is a high-tension suture fixation with a button based anchor system.
Arthrex Tightrope
High-tensile strength suture syndesmosis repair
Synthes Fibulink
Syndesmosis fixation perforemd with Synthes Fibulink device. This is a high-tension fixation with a screw based anchor system.
Synthes Fibulink
High-tensile strength suture syndesmosis repair
Interventions
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Arthrex Tightrope
High-tensile strength suture syndesmosis repair
Synthes Fibulink
High-tensile strength suture syndesmosis repair
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older
* Ability to understand the content of the patient information/informed consent form
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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William Kent
Assistant Professor of Orthopaedic Surgery
Locations
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University of California, San Diego
San Diego, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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800669
Identifier Type: -
Identifier Source: org_study_id
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