Safety and Efficacy of the ANTHEMâ„¢ CR Total Knee System (NCT03885622) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Efficacy of the ANTHEMâ„¢ CR Total Knee System
India, Italy153 participantsStarted 2018-11-23
Plain-language summary
This clinical study will evaluate the short-term (1- and 2-year) and medium term (5-year) safety and performance of the ANTHEMâ„¢ 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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:
✕. 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.