NCT06085586 Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
| NCT ID | NCT06085586 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maimonides Medical Center |
| Condition | Ankle Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2023-07-13 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 56 participants in total. It began in 2023-07-13 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Amr A Abdelgawad, MD PhD MBA
PRINCIPAL INVESTIGATOR
Vice Chair of Orthopedic Clinical Programs, Director of Pediatric Orthopedic Surgery
Frequently Asked Questions
Who can join the NCT06085586 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Ankle Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06085586 currently recruiting?
Yes, NCT06085586 is actively recruiting participants. Contact the research team at aabdelgawad@maimonidesmed.org for enrollment information.
Where is the NCT06085586 trial being conducted?
This trial is being conducted at Brooklyn, United States.
Who is sponsoring the NCT06085586 clinical trial?
NCT06085586 is sponsored by Maimonides Medical Center. The principal investigator is Amr A Abdelgawad, MD PhD MBA at Vice Chair of Orthopedic Clinical Programs, Director of Pediatric Orthopedic Surgery. The trial plans to enroll 56 participants.