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LEGION Hinge Safety and Efficacy Study — LINKS  

Knee Arthroplasty, Total Clinical Trial

Official title:
A Prospective, Multi-center Clinical Study Evaluating the LEGION™ Hinge Knee System

Clinical Trial Summary

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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02445443
Study type Observational
Source Smith & Nephew, Inc.
Contact
Status Active, not recruiting
Phase
Start date June 30, 2015
Completion date August 1, 2028
View Details
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