Safety and Efficacy of the ANTHEM™ CR Total Knee System

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).

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.
• Subject has collateral ligament insufficiency.
• Subject has an active infection or sepsis (treated or untreated) or previous intra-articular infections.
• Subject has presence of malignant tumor, either primary or metastatic, or benign tumor on leg with the knee to be treated.
• Subject has conditions that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes mellitus [i.e. not under treatment with oral/injectable medications to control blood glucose levels], fibromyalgia, moderate to severe renal insufficiency or neuromuscular disease).
• Subject has contralateral lower extremity condition causing abnormal ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture).
• Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
• Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study, including mental illness, mental retardation, drug or alcohol abuse.
• Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1.
• Any subject that meets the definition of a Vulnerable Subject per ISO14155:2011: individual whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate.