NCT06085586
Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Recruiting
NAAges 22+InterventionalTreatmentMaimonides Medical CenterInvestigator-initiated
~56 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:Early Weight BearingNormal Weight Bearing
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
6 Month Reduction Quality
Measured over 6 Months
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Amr A Abdelgawad, MD PhD MBA · PRINCIPAL_INVESTIGATOR · Vice Chair of Orthopedic Clinical Programs, Director of Pediatric Orthopedic Surgery
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
ankle fracture with syndesmotic disruption as assessed with intra-operative cotton test.
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
What this trial measures
- 6 Month Reduction Quality6 Months
The primary objective is to evaluate the reduction and maintenance of the reduction of ankle syndesmosis in 6 months after initiating full weight bearing (100%) at 4 weeks or 6 weeks postoperatively. This will be determined based on comparing the tibiofibular overlap, tibiofibular clear space and medial clear space preoperative values.