Last updated on January 2019

Ten Year Implant Survivorship of the ANTHEM Total Knee System


Brief description of study

The ANTHEM 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 Study Description

The ANTHEM Study is a prospective, multicentre, cohort study to collect relevant patient reported, clinical, surgical and radiological data from 196 subjects implanted with the ANTHEM 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 Knee System over 10 years. This is a post-market study of the ANTHEM Total Knee System.

The primary objective of the study is to demonstrate non-inferiority (5% margin) of 10 year implant survivorship of the ANTHEM 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 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)

Clinical Study Identifier: NCT03078543

Contact Investigators or Research Sites near you

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Robert McLennan-Smith

Westville Hospital
Durban, South Africa
1.23miles
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Recruitment Status: Open


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