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First received: October 10, 2023

Clinical Trial: Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

Study Status: Completed

Recruit Status: RECRUITING

Condition: Ankle Fractures

Study Type: INTERVENTIONAL


Official Title: Evaluation of Safety and Performance Outcomes of the Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

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.6,7Malreduction and instability of the distal tibiotalar joint can lead to chronic instability, increased articular damage and ultimately degenerative arthritis.7,8Medial to lateral translation of distal tibia and fibula of 2 mm or more has been…

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