Actively Recruiting
Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Led by Maimonides Medical Center · Updated on 2026-03-20
56
Participants Needed
1
Research Sites
181 weeks
Total Duration
On this page
Sponsors
M
Maimonides Medical Center
Lead Sponsor
J
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ankle fracture with syndesmotic disruption confirmed by intra-operative cotton test
- Includes syndesmotic sprain without fractures
- Includes bimalleolar equivalent ankle fractures
- Includes bimalleolar ankle fractures
- Includes Maisonneuve fractures
- Includes trimalleolar ankle fractures without need for posterior malleolus fixation
- Includes ankle fracture dislocations
You will not qualify if you...
- Previous ankle surgery
- Active local infection around the ankle
- Chronic ankle deformity from trauma or congenital causes
- Ligamentous laxity
- Pathologic fractures
- Peripheral vascular disease
- Peripheral neuropathy
- Diabetes neuropathy and Charcot joint
- Open fractures
- Polytrauma
- Inability to provide informed consent
- Symptomatic ankle osteoarthritis
- Retained hardware in the ankle
- Pregnant
- Metabolic bone disease
- History of chronic steroid use
- Mal-reduced ankle fractures
AI-Screening
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Trial Site Locations
Total: 1 location
1
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Actively Recruiting
Research Team
A
Amr A Abdelgawad, MD PhD MBA
CONTACT
A
Ariel N Rodriguez, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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