A Prospective, Multicentre, Cohort Study Assessing the Safety and Efficacy of the ANTHEM™ PS Total Knee System in Patients Following a Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 148
- 试验地点
- 8
- 主要终点
- Ten year Anthem knee implant survivorship
研究概览
简要总结
The ANTHEM™PS Total Knee System is being conducted to demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature
详细描述
The ANTHEM PS Study is a prospective, multicentre, cohort study to collect relevant patient reported, clinical, surgical and radiological data from 143 subjects implanted with the ANTHEM™PS Knee System for degenerative joint disease in up to 6 clinical sites globally. Total study duration for study participants will be 10 years with post-operative follow-up visits planned for 6 weeks, 1 year, 2 years, 5 years, 7.5 years and 10 years. The study will evaluate the 10 year implant survivorship and the safety and outcome of the ANTHEM™PS Knee System over 10 years. This is a post-market study of the ANTHEM™PS Total Knee System.
The primary objective of the study is to demonstrate non-inferiority (8% margin) of 10 year implant survivorship of the ANTHEM™PS Total Knee System in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature.
The secondary objectives of the study are to evaluate shorter and long term safety and outcomes of the ANTHEM™ PS Total Knee System.
- Knee injury and Osteoarthritis Outcomes Score (KOOS)
- 2011 Knee Society Score (2011 KSS)
- EQ-5D - 3L
- Femoral Fit ('Perfect Fit' rate)
- Radiographic Assessment
- Revision for any reason
- Adverse Events (AEs)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 is male or female between the ages of 18 and 75 years of age
- •Subject plans to be available through ten (10) years post-operative follow-up
- •Subject agrees to follow the study protocol
排除标准
- •Subject would receive the ANTHEM™ Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty
- •Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
- •Subject has a history of patellar fracture, patellectomy, 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 total knee or unicondylar knee arthroplasty
- •Subject has an active infection or sepsis (treated or untreated)
- •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 a chronic, contralateral lower extremity condition causing abnormal ambulation, which is not related to the knee (e.g. ankle fusion, ankle arthroplasty, previous hip fracture).
- •Subject is pregnant or plans to become pregnant during the study
- •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
- •Subject has a BMI>40
- •Subject is enrolled in another investigational drug, biologic, or device study
- •Subject is facing current or impending incarceration
- •Subject has an inadequate bone stock to support the device which would make the procedure unjustifiable, including but not limited to: severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia
研究组 & 干预措施
ANTHEM™ PS Total Knee System implant
The ANTHEM™ PS Total Knee System will demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature
干预措施: ANTHEM™ PS Total Knee System implant (Device)
结局指标
主要结局
Ten year Anthem knee implant survivorship
时间窗: Study participants will be followed for 10 years
The ANTHEM™ Total Knee System will demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature
次要结局
- 2011 Knee Society Score (2011 KSS)(Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5 and 10 years)
- Knee injury and Osteoarthritis Outcomes Score (KOOS)(Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5 and 10 years)
- Femoral Fit ('Perfect Fit' rate)(Femoral Fit will be measured at surgery, assessed for an estimated 1 hour)
- Revision for any reason(Anytime during the 10 year study period)
- Radiographic Assessments to adequately assess the component position, prosthesis-bone interface, and the knee alignment.(Radiographic assessments to be conducted at Pre-operation timepoint (Baseline), post-operative (Day 1), 6 weeks, 1,2, 5, and 10 years)
- Adverse Events(Adverse events are collected at any time during the study with formal timepoints being at surgery, 6 weeks, 1,2, 5, 7.5 and 10 years)
- EQ-5D-3L(Participant questionnaire completed at the Baseline timepoint, 6 weeks, 1,2, 5, 7.5 and 10 years)