Last updated on June 2018

LEGION Hinge Safety and Efficacy Study

Brief description of study

The purpose of the current investigation is to assess the safety and efficacy of a new hinged revision knee device. This device is designed to provide efficient, reproducible reconstructions with optimal limb and implant alignment, durable implant fixation, and functional outcomes that increasingly approach those of primary Total Knee Arthroplasty (TKA).

Detailed Study Description

The objective of this study is to demonstrate statistically significant improvements in the original Knee Society Clinical Score (KSCS) from baseline to 1 and 2 years in subjects using the LEGION Hinge Knee System. The focus of the 1 and 2 year analyses will be on safety and efficacy. The 5 year analysis will focus on survivorship and safety.

Clinical Study Identifier: NCT02445443

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Ran Schwarzkopf, MD

NYU Hospital for Joint Diseases
New York, NY United States
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David Mayman, MD

Hospital for Special Surgery
New York, NY United States
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Gerhard E Maale, MD

Baylor Research Institute at Baylor Regional Medical Center Plano
Plano, TX United States
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Piers Yates, MD

Fremantle Hospital
Fremantle, Australia
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Piers Yates, MD

Orthopaedics WA St John of God Hospital Murdoch
Murdoch, Australia
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Thomas Turgeon, MD

Concordia Hip and Knee Institute
Winnipeg, MB Canada
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Alfredo Matamala Pérez, MD

University Hospital Mutua de Terrassa
Terrassa, Spain
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Hilde Vandenneucker, MD

UZ Leuven campus Pellenberg
Pellenberg, Belgium
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