Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Evaluation of Safety and Performance Outcomes of the Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Maimonides Medical Center
56 participants
Jul 13, 2023
INTERVENTIONAL
Conditions
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 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 is delayed weight bearing due to risk of screw breakage.1 Suture button technique allowed for early weight bearing with average of 6 weeks postoperatively using TightRope.2,10-12By initiating full weight bearing (100%) with CAM boot at 4 weeks postoperatively, this would be a significant improvement in current clinical practice.
Eligibility
Inclusion Criteria8
- 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 Criteria1
- \) 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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Interventions
Full weight bearing (100%) initiated at 4 weeks postoperatively
Full weight bearing (100%) initiated at 6 weeks postoperatively
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06085586