Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Maimonides Medical Center
Study ID
NCT06085586
Status
Recruiting
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Conditions

  • Ankle Dislocation
  • Ankle Fractures
  • Bimalleolar Equivalent Fracture
  • Bimalleolar Fractures
  • Maisonneuve Fracture
  • Syndesmotic Injuries
  • Trimalleolar Fractures

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Early Weight Bearing — OTHER
    Full weight bearing (100%) initiated at 4 weeks postoperatively
  • Normal Weight Bearing — OTHER
    Full weight bearing (100%) initiated at 6 weeks postoperatively

Study Details

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.

Key Dates

Start date
Jul 13, 2023
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1) Early Full Weight Bearing
    Full weight bearing (100%) initiated at 4 weeks postoperatively
  • Active Comparator: 2) Normal Full Weight Bearing
    Full weight bearing (100%) initiated at 6 weeks postoperatively

Primary Outcome Measure

6 Month Reduction Quality [ Time Frame: 6 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Maimonides Medical CenterBrooklynNew York11219
Antonios Likourezos
[email protected]
718-283-6896
Amr A Abdelgawad, MD PhD MBA (PRINCIPAL_INVESTIGATOR)
Aaron W Lam, MD (SUB_INVESTIGATOR)

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