Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Stemmed CS Femur With the EVOLUTION® MP CS Tibial Insert
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The proportion of EVOLUTION® MP CS tibial inserts survivorship out to 10 years.
研究概览
简要总结
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® Revision Tibial System and EVOLUTION® Revision STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.
详细描述
The primary objective of this study is to estimate individual component survivorship for tibial base, femoral component, and tibial insert at specified intervals out to 10 years follow-up.
The secondary objectives include:
- Determine the cumulative incidence of individual component revision at specified intervals out to 10 years follow-up;
- Characterize functional scores for subjects, as assessed by KOOS Scores and EQ-5D-5L Scores, out to 10 years follow-up;
- To assess subject satisfaction with their TKA procedure using the Forgotten Joint Score and a Satisfaction Survey;
- To assess the presence, zone, and the size of radiolucencies surrounding implanted components out to 10 years follow-up;
- To assess safety and characterize protocol defined adverse events and adverse device effects.
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
- •Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires implantation of the components under study (EVOLUTION® Revision Tibial System and EVOLUTION® STEMMED CS Femur with the EVOLUTION® MP CS Tibial Insert)
- •Decision to perform the study index surgery with the required study components is pre-determined regardless of the research;
- •Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their study index surgery
- •Willing to voluntarily sign the informed consent form
- •Willing and able to comply with the protocol, able to read and complete the required forms, and willing and able to adhere to the requirements of the protocol through the 10-year postoperative follow-up visit.
排除标准
- •Skeletally immature (less than 21 years of age) at time of implantation
- •Has or had an overt infection at the time of implantation
- •Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
- •Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- •Has or had documented substance abuse issues
- •Has or had an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- •Currently incarcerated or has impending incarceration
- •Has a medical condition, as judged by the Investigator, that would interfere with the subject's ability to comply with the requirements of the protocol
结局指标
主要结局
The proportion of EVOLUTION® MP CS tibial inserts survivorship out to 10 years.
时间窗: up to 10 years
Percentage of knees survived with no revision or replacement at 10-year
The proportion of EVOLUTION® Revision Tibial Base components survivorship out to 10 years.
时间窗: up to 10 years
Percentage of knees survived with no revision or replacement at 10-year
The proportion of EVOLUTION® STEMMED CS Femoral components survivorship out to 10 years.
时间窗: up to 10 years
Percentage of knees survived with no revision or replacement at 10-year
次要结局
- To assess subject safety: Adverse Events o Adverse Events related to study device or the index surgical procedure(Year 1,Year 3, Year 5, Year 7, and Year 10)
- Incidence of component revision(Year 1,Year 3, Year 5, Year 7, and Year 10)
- Functional Scores(Year 1,Year 3, Year 5, Year 7, and Year 10)
- Subject Satisfaction(Year 1,Year 3, Year 5, Year 7, and Year 10)
- Radiolucencies(Year 1,Year 3, Year 5, Year 7, and Year 10)