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Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

NCT06085586 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-03-20

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

Early Weight Bearing

Full weight bearing (100%) initiated at 4 weeks postoperatively

OTHER

Normal Weight Bearing

Full weight bearing (100%) initiated at 6 weeks postoperatively

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    collaborator INDUSTRY

  • Maimonides Medical Center

    lead OTHER

Principal Investigators

  • Amr A Abdelgawad, MD PhD MBA · Vice Chair of Orthopedic Clinical Programs, Director of Pediatric Orthopedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-13
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06085586 on ClinicalTrials.gov