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.
ankle fracture with syndesmotic disruption as assessed with intra-operative cotton test.
Syndesmotic sprain (without fractures)
Bimalleolar equivalent ankle fractures
Bimalleolar ankle fractures
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
Parallel
Early Weight Bearing
Other interventionFull weight bearing (100%) initiated at 4 weeks postoperatively
Normal Weight Bearing
Other interventionFull weight bearing (100%) initiated at 6 weeks postoperatively
6 Month Reduction Quality
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.
2 Week Reduction Quality
Reduction and maintenance of the reduction of the ankle syndesmosis at 2 weeks based on the tibiofibular overlap, tibiofibular clear space and medial clear space preop values.
4-6 Week Reduction Quality
Reduction and maintenance of the reduction of the ankle syndesmosis at 4-6 weeks based on the tibiofibular overlap, tibiofibular clear space and medial clear space preop values.
8-10 Week Reduction Quality
Reduction and maintenance of the reduction of the ankle syndesmosis at 8-10 weeks based on the tibiofibular overlap, tibiofibular clear space and medial clear space preop values.
3 Month Reduction Quality
Reduction and maintenance of the reduction of the ankle syndesmosis at 3 months based on the tibiofibular overlap, tibiofibular clear space and medial clear space preop values.
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Maimonides Medical Center
Lead sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator
