NCT03885622

Safety and Efficacy of the ANTHEM™ CR Total Knee System

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 153 (actual)
• Sponsor: Smith & Nephew Pte Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Non-inflammatory Degenerative Joint Disease

Interventions

Type	Name	Description
DEVICE	ANTHEM™ CR Total Knee System	The ANTHEM CR Total Knee System is a CE marked device. It is a cruciate retaining (CR) total knee system. It is intended to be used in patients for primary total knee replacement surgery where the posterior cruciate ligament and collateral ligaments remain intact. It is a comprehensive system which allows surgeons to address simple to complex knee arthroplasties.

Timeline

• Start date: 2018-11-23
• Primary completion: 2034-04-03
• Completion: 2034-08-01
• First posted: 2019-03-21
• Last updated: 2026-03-10

Locations

8 sites across 4 countries: India, Italy, South Africa, South Korea