NCT03078543

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 148 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed 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)

Conditions

• Arthroplasty, Replacement, Knee

Interventions

Type	Name	Description
DEVICE	ANTHEM™ PS Total Knee System implant	The ANTHEM™ PS Total Knee System is a comprehensive system which allows surgeons to address simple to complex knee arthroplasties. The ANTHEM™ PS Total Knee System consists of the following components: * Cobalt-Chrome (Co-Cr) femoral components - Posterior stabilised * Titanium primary tibial components * Posterior-stabilised ultra-high molecular weight polyethylene (UHMWPE) * Polyethylene patella components The resulting product is sufficient to accommodate a wide range of clinical applications.

Timeline

• Start date: 2017-06-28
• Primary completion: 2029-04-30
• Completion: 2029-04-30
• First posted: 2017-03-13
• Last updated: 2026-03-11

Locations

8 sites across 5 countries: China, Italy, South Africa, South Korea, Thailand

Regulatory

• FDA-regulated device study