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.
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).
Study Type
OBSERVATIONAL
Enrollment
153
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.
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, Italy
Non-Inferiority 10 years postoperatively
Non-inferiority of 10-year implant survivorship of the ANTHEM™ CR Total Knee System in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature.
Time frame: 10 years postoperatively
Change in implant fixation measured by radiographic assessment
based on comparison of antero posterior and lateral radiographs
Time frame: 6 weeks, 1 year, 2 years, and 5 years
Change in bone integrity measured by radiographic assessment
based on comparison of antero-posterior and lateral radiographs
Time frame: 6 weeks, 1 year, 2 years, and 5 years
Number of Adverse Events
Number and frequency of all types adverse events
Time frame: 6 weeks, 1 year, 2 years, and 5 years
Quality of life measured by EQ-5D-3L
The EQ-5D-3L will be collected at each follow up visit. It consists of two pages - the EQ-5D descriptive system (page one) and the EQ visual analogue scale (EQ VAS) (page two). The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses.
Time frame: 6 weeks, 1 year, 2 years, and 5 years
Pain as measured by Knee Society Score (2011 KSS)
This validated tool that combines an objective physician-derived component with a subjective subject-derived component. The objective section rates alignment, instability, joint motion and symptoms.
Time frame: 6 weeks, 1 year, 2 years, and 5 years
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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