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Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

NCT06085586

This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .

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…

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

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

Eligibility basics and study details

Study type
Interventional
Phase
Not applicable
Ages
22 years and older
Sex
All
Healthy volunteers
Accepted
Sponsor
Maimonides Medical Center
Last updated on ClinicalTrials.gov
March 20, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

New York · 1

  • Maimonides Medical Center · Brooklyn, NY

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.