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Safety and Efficacy of the ANTHEM™ CR Total Knee System — Anthem CR  

Non-inflammatory Degenerative Joint Disease Clinical Trial

Official title:
A Prospective, Multicentre, Cohort Study Assessing the Safety and Efficacy of the ANTHEM™ CR Total Knee System in Patients Following a Total Knee Arthroplasty

Clinical Trial Summary

This clinical study will evaluate the short-term (1- and 2-year) and medium term (5-year) safety and performance of the ANTHEM™ CR Total Knee System in patients with non-inflammatory degenerative joint disease of the knee requiring total knee replacement. Clinical, radiographic, Health Economic Outcomes and safety outcomes will be evaluated.

Clinical Trial Description

To assess the safety and performance of the ANTHEM™ CR Total Knee System in patients with degeneration of the knee by demonstrating non-inferiority in the revision-free survival rate at 5 years compared to a literature reference rate of 96.6% (Australian Orthopaedic Association annual report 2016). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03885622
Study type Observational
Source Smith & Nephew, Inc.
Contact
Status Active, not recruiting
Phase
Start date November 23, 2018
Completion date March 1, 2033
View Details
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