Safety and Efficacy of the ANTHEM™ CR Total Knee System
- Conditions
- Non-inflammatory Degenerative Joint Disease
- Registration Number
- NCT03885622
- Lead Sponsor
- Smith & Nephew Pte Ltd
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 153
- 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.
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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).
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Subject received TKA on the contralateral knee as a revision for a previously failed TKA or UKA.
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Subject has a history of patellar fracture, patellectomy, or patello-femoral Instability.
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Subject has inflammatory arthritis.
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Subject possesses a contralateral or ipsilateral revision hip arthroplasty.
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Subject has ipsilateral hip arthritis resulting in flexion contracture.
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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.
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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.
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Subject has collateral ligament insufficiency.
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Subject has an active infection or sepsis (treated or untreated) or previous intra-articular infections.
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Subject has presence of malignant tumor, either primary or metastatic, or benign tumor on leg with the knee to be treated.
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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).
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Subject has contralateral lower extremity condition causing abnormal ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture).
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Women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures.
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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.
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Participation in the treatment period of another clinical trial within thirty (30) days of Visit 1.
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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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Non-Inferiority 10 years postoperatively 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 Outcome Measures
Name Time Method Change in implant fixation measured by radiographic assessment 6 weeks, 1 year, 2 years, and 5 years based on comparison of antero posterior and lateral radiographs
Change in bone integrity measured by radiographic assessment 6 weeks, 1 year, 2 years, and 5 years based on comparison of antero-posterior and lateral radiographs
Number of Adverse Events 6 weeks, 1 year, 2 years, and 5 years Number and frequency of all types adverse events
Pain as measured by Knee Society Score (2011 KSS) 6 weeks, 1 year, 2 years, and 5 years This validated tool that combines an objective physician-derived component with a subjective subject-derived component. The objective section rates alignment, instability, joint motion and symptoms.
Quality of life measured by EQ-5D-3L 6 weeks, 1 year, 2 years, and 5 years The EQ-5D-3L will be collected at each follow up visit. It consists of two pages - the EQ-5D descriptive system (page one) and the EQ visual analogue scale (EQ VAS) (page two). The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses.
Trial Locations
- Locations (8)
Parekhs Hospital
🇮🇳Ahmedabad, Gujarat, India
Aadhar Health Institute
🇮🇳Hisar, Haryana, India
Ivy Hospital - Ivy Elite Institute of Orthopaedics
🇮🇳Mohali, Punjab, India
Westville Hospital
🇿🇦Westville, Durban, South Africa
Instituto Clinico Sant'Ambrogio
🇮🇹Milan, Italy
Istituto Clinico San Siro
🇮🇹Milano, Italy
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Jeonranam-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Korea, Republic of