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Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

RecruitingNAAges 22 Years - anyAllMaimonides Medical Center
NCT06085586 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 the changes in tibiotalar contact pressure observed in cadaveric studies.6,7 Malreduction and instability of the distal tibiotalar joint can lead to chronic instability, increased articular damage and ultimately degenerative arthritis.7,8 Medial to lateral translation of distal tibia and fibula of 2 mm or more has been considered pathologic.9 Earlier biomechanical study demonstrated the Fibulink system is superior in maintaining displacement of less than 2 mm.4 Given the improved strength, we also look to evaluate the outcomes of initiating full weight bearing (100%) with Controlled Ankle Motion (CAM) boot at 4 weeks postoperatively. One of the big limitations for trans-osseous screw fixation

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Early Weight Bearing
  • Normal Weight Bearing
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Where

1 site
Maimonides Medical Center
Brooklyn, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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