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Safety and Efficacy of the ANTHEM™ CR Total Knee System
Sponsor: Smith & Nephew Pte Ltd
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
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