A Prospective, Multicentre, Cohort Study Assessing the Safety and Efficacy of the ANTHEM™ CR Total Knee System in Patients Following a Total Knee Arthroplasty

Smith & Nephew Pte Ltd8 sites in 4 countries153 target enrollmentNovember 23, 2018

ConditionsNon-inflammatory Degenerative Joint Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Non-inflammatory Degenerative Joint Disease
Sponsor: Smith & Nephew Pte Ltd
Enrollment: 153
Locations: 8
Primary Endpoint: Non-Inferiority 10 years postoperatively
Status: Active, Not Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

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).

Registry

clinicaltrials.gov

Start Date

November 23, 2018

End Date

August 1, 2034

Last Updated

last month

Study Type

Observational

Sex

All

Investigators

Sponsor

Smith & Nephew Pte Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is a candidate for primary total knee arthroplasty due to degenerative joint disease.
•Subject is willing to sign and date an EC-approved consent form.
•Subject has posterior cruciate ligament and all collateral ligaments intact in the index joint.
•Subject is 18 to 75 years old at time of inclusion.
•Subject plans to be available through ten (10) years postoperative follow-up.
•Subject agrees to follow the study protocol.
•Subject has achieved skeletal maturity as deemed by enrolling investigator.

Exclusion Criteria

•Subject would receive the ANTHEM™ CR Total Knee System on the affected knee as a revision for a previously failed (TKA) or unicondylar knee arthroplasty (UKA).
•Subject received TKA on the contralateral knee as a revision for a previously failed TKA or UKA.
•Subject has a history of patellar fracture, patellectomy, or patello-femoral Instability.
•Subject has inflammatory arthritis.
•Subject possesses a contralateral or ipsilateral revision hip arthroplasty.
•Subject has ipsilateral hip arthritis resulting in flexion contracture.
•Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the Investigator:
•Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty.
•Contralateral primary TKA or UKA.
•Inadequate bone stock which would make the procedure unjustifiable including but not limited to: severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia as deemed by the enrolling investigator.

Outcomes

Primary Outcomes

Non-Inferiority 10 years postoperatively

Time Frame: 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.

Secondary Outcomes

Change in implant fixation measured by radiographic assessment(6 weeks, 1 year, 2 years, and 5 years)
Change in bone integrity measured by radiographic assessment(6 weeks, 1 year, 2 years, and 5 years)
Number of Adverse Events(6 weeks, 1 year, 2 years, and 5 years)
Pain as measured by Knee Society Score (2011 KSS)(6 weeks, 1 year, 2 years, and 5 years)
Quality of life measured by EQ-5D-3L(6 weeks, 1 year, 2 years, and 5 years)