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ACTIVE NOT RECRUITING
NCT03885622

Safety and Efficacy of the ANTHEM™ CR Total Knee System

Sponsor: Smith & Nephew Pte Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

153

Start Date

2018-11-23

Completion Date

2034-08-01

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

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.

Locations (8)

Parekhs Hospital

Ahmedabad, Gujarat, India

Aadhar Health Institute

Hisar, Haryana, India

Ivy Hospital - Ivy Elite Institute of Orthopaedics

Mohali, Punjab, India

Instituto Clinico Sant'Ambrogio

Milan, Milan, Italy

Istituto Clinico San Siro

Milan, Italy

Westville Hospital

Westville, Durban, South Africa

Chonnam National University Hwasun Hospital

Hwasun, Jeonranam-do, South Korea

Gachon University Gil Medical Center

Incheon, Korea, South Korea