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Ten Year Implant Survivorship of the ANTHEM™ PS Total Knee System — ANTHEM PS  

Arthroplasty, Replacement, Knee Clinical Trial

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

Clinical Trial Summary

The ANTHEM™PS Total Knee System is being conducted to demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature

Clinical Trial Description

The ANTHEM PS Study is a prospective, multicentre, cohort study to collect relevant patient reported, clinical, surgical and radiological data from 143 subjects implanted with the ANTHEM™PS Knee System for degenerative joint disease in up to 6 clinical sites globally. Total study duration for study participants will be 10 years with post-operative follow-up visits planned for 6 weeks, 1 year, 2 years, 5 years, 7.5 years and 10 years. The study will evaluate the 10 year implant survivorship and the safety and outcome of the ANTHEM™PS Knee System over 10 years. This is a post-market study of the ANTHEM™PS Total Knee System. The primary objective of the study is to demonstrate non-inferiority (8% margin) of 10 year implant survivorship of the ANTHEM™PS Total Knee System in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature. The secondary objectives of the study are to evaluate shorter and long term safety and outcomes of the ANTHEM™ PS Total Knee System. - Knee injury and Osteoarthritis Outcomes Score (KOOS) - 2011 Knee Society Score (2011 KSS) - EQ-5D - 3L - Femoral Fit ('Perfect Fit' rate) - Radiographic Assessment - Revision for any reason - Adverse Events (AEs) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03078543
Study type Interventional
Source Smith & Nephew, Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date June 28, 2017
Completion date December 30, 2029
View Details
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