Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Ankle Fractures, Bimalleolar Fractures, Syndesmotic Injuries
About this trial
This is an interventional treatment trial for Ankle Fractures focused on measuring Ankle Fractures, Bimalleolar Fractures, Bimalleolar Equivalent Fracture, Trimalleolar Fractures, Maisonneuve Fractures, Syndesmotic Injuries, Ankle Dislocations
Eligibility Criteria
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
Sites / Locations
- Maimonides Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1) Early Full Weight Bearing
2) Normal Full Weight Bearing
Full weight bearing (100%) initiated at 4 weeks postoperatively
Full weight bearing (100%) initiated at 6 weeks postoperatively