Post Market Clinical Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System With Cruciate Sacrificing Inserts
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Component Survivorship
研究概览
简要总结
MPO is conducting this PMCF study to evaluate the safety and efficacy of its EVOLUTION® Total Knee Arthroplasty (TKA) components marketed in the EU. These types of studies are required by regulatory authorities for all devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.
详细描述
MicroPort Orthopedics Inc. (MPO) currently markets the EVOLUTION® TKA System globally, including in the European Union (EU). As part of the process for gaining approval to market in the EU, MicroPort is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of this system. These types of studies are required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. The objectives of this study are to evaluate component survivorship, cumulative revision rate, functional outcome scores, and subject satisfaction at early, midterm, and long-term follow-up.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be included in the study, subjects must meet all of the following criteria:
- •Has previously undergone primary TKA for any of the following:
- •non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- •inflammatory degenerative joint disease including rheumatoid arthritis
- •correction of functional deformity.
- •Subject was implanted with the specified combination of components
- •Subject is willing and able to complete required study visits and assessments
- •Subject plans to be available through the 10 year postoperative follow-up visit
- •Subject is willing to sign the approved Informed Consent document
- •Subject must be at least 2 years post TKA prior to informed consent.
- •Previously implanted bilateral subjects can have both TKAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and 4) the subject agrees to a second Informed Consent document specific to the second TKA. Prospective enrollment of a previously unimplanted knee is not permitted in this study.
排除标准
- •Subjects will be excluded if they meet any of the following criteria:
- •Subject was skeletally immature (less than 21 years of age) at time of implantation
- •Subject is currently enrolled in another clinical investigation
- •Subject is unwilling or unable to sign the Informed Consent document
- •Subject has documented substance abuse issues
- •Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- •Subject has a body mass index (BMI) of greater than 40
- •Subject is currently incarcerated or has impending incarceration
结局指标
主要结局
Component Survivorship
时间窗: 10 years post-operative
The primary endpoints are analysis of survivorship for all components at each follow-up interval out to 10 years
次要结局
- Cumulative Revision Rate(2-<5 years, 5-7 years, and 10 years)
- Subject Satisfaction (assessed by Patient Satisfaction Questionnaires)(2-<5 years, 5-7 years, and 10 years)
- Patient functional outcomes scores (assessed by KOOS Scores and EQ-5D-3L Scores)(2-<5 years, 5-7 years, and 10 years)
- Size of Radiolucencies(2-<5 years, 5-7 years, and 10 years)
- Number of Radiolucencies(2-<5 years, 5-7 years, and 10 years)