CTRI/2019/01/017098
Recruiting
Phase 4
A Prospective, Multicentre, Cohort Study Assessing theSafety and Efficacy of the ANTHEMâ?¢ CR Total KneeSystem in Patients following a Total Knee Arthroplasty
Smith and Nephew Orthopaedics AG0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: Z471- Aftercare following joint replacement surgery
- Sponsor
- Smith and Nephew Orthopaedics AG
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject is a candidate for primary total knee arthroplasty due to degenerative joint disease.
- •2\. Subject is willing to sign and date an EC\-approved consent form.
- •3\. Subject has posterior cruciate ligament and all collateral ligaments intact in the index joint.
- •4\. Subject is 18 to 75 years old at time of inclusion.
- •5\. Subject plans to be available through five (5\) years postoperative follow\-up.
- •6\. Subject agrees to follow the study protocol.
- •7\. Subject has achieved skeletal maturity as deemed by enrolling investigator.
Exclusion Criteria
- •1\. 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).
- •2\. Subject received TKA on the contralateral knee as a revision for a previously failed TKA or UKA.
- •3\. Subject has a history of patellar fracture, patellectomy, or patello\-femoral Instability.
- •4\. Subject has inflammatory arthritis.
- •5\. Subject possesses a contralateral or ipsilateral revision hip arthroplasty.
- •6\. Subject has ipsilateral hip arthritis resulting in flexion contracture.
- •7\. 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.
- •8\. 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
Not specified
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