Status:
RECRUITING
Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Lead Sponsor:
Maimonides Medical Center
Collaborating Sponsors:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Ankle Fractures
Bimalleolar Fractures
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate the ability of the Fibulink Syndesmosis Repair System to maintain reduction of the ankle syndesmosis. Appropriate reduction of the syndesmosis is critical due t...
Detailed Description
All ankle fractures will be evaluated by the orthopedic team. Standard radiographs including anteroposterior (AP), lateral and mortise view of the ankle will be obtained. Manual or gravity stress view...
Eligibility Criteria
Inclusion
- ankle fracture with syndesmotic disruption as assessed with intra-operative cotton test.
- This includes the following injuries:
- Syndesmotic sprain (without fractures)
- Bimalleolar equivalent ankle fractures
- Bimalleolar ankle fractures
- Maisonneuve fractures
- Trimalleolar ankle fractures without the need for posterior malleolus fixation
- Ankle fracture dislocations
Exclusion
- 1\) previous ankle surgery, 2) active local infection about the ankle, 3) chronic ankle deformity secondary to trauma or congenital, 4) ligamentous laxity, 5) pathologic fractures, 6) peripheral vascular disease, 7) peripheral neuropathy, 8) diabetes neuropathy and charcot, 9) open fractures, 10) poly trauma, 11) inability to provide informed consent, 12) symptomatic ankle osteoarthritis, 12) retained hardware, 13) pregnant, 14) metabolic bone disease, 15) history of chronic steroid use, 16) mal-reduced ankle fractures
Key Trial Info
Start Date :
July 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06085586
Start Date
July 13 2023
End Date
June 30 2026
Last Update
November 5 2025
Active Locations (1)
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1
Maimonides Medical Center
Brooklyn, New York, United States, 11219