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Safety and Efficacy of the ANTHEM™ CR Total Knee System

NCT03885622 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 153

Last updated 2026-03-10

No results posted yet for this study

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.

Conditions

  • Non-inflammatory Degenerative Joint Disease

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.

Sponsors & Collaborators

  • Smith & Nephew Pte Ltd

    lead INDUSTRY

Principal Investigators

  • Jae Ang Sim, M.D. · Gachon University Gil Medical

  • Manuj Wadhwa, M.D. · Ivy Hospital - Ivy Elite Institute of Orthopaedics

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-23
Primary Completion
2034-04-03
Completion
2034-08-01

Countries

  • India
  • Italy
  • South Africa
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03885622 on ClinicalTrials.gov