NCT04145401Enrolling By Invitation不适用
Post Market Clinical Follow-Up Study for EVOLUTION® Revision Tibial System and EVOLUTION® Revision Constrained Condylar Knee (CCK) Femur With the EVOLUTION® CCK Tibial Insert
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Individual component survivorship
研究概览
简要总结
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its EVOLUTION® Revision CCK Tibia and EVOLUTION® Revision CCK Femur with EVOLUTION® CCK Tibial inserts. These type of studies are required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 rev 2 (European Medical Device Vigilance System) and ISO (International Organization for Standardization) 14155:2011 guidelines.
详细描述
The objectives of this study are:
- To estimate the individual component survivorship of EVOLUTION® Revision Tibia, EVOLUTION® Revision CCK Femur, and EVOLUTION® CCK Tibial Insert.
- To find out the cumulative incidence of component revision of each component in this combination.
- To find out the functional outcome scores 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
- •Has previously undergone or currently has been determined to undergo a revision knee arthroplasty that requires the study (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert)
- •Decision to perform the study index surgery with the required study components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) is pre-determined regardless of the research.
- •Previously implanted subjects must be enrolled within 3 years (+6 months) of their study index surgery
- •Willing and able to complete required study visits and assessments through the 10 year post-operative follow-up visit.
- •Bilateral subjects can have both TKAs enrolled in the study provided:
- •the specified combination of components (EVOLUTION® Revision Tibial System and EVOLUTION® Revision CCK Femur with the EVOLUTION® CCK Tibial Insert) were implanted in both
- •all other aspects of the Inclusion/Exclusion Criteria are satisfied
- •enrollment does not exceed the subject count specified
- •the subject agrees to a second Informed Consent document and data collection specific to the second TKA.
排除标准
- •Skeletally immature (less than 21 years of age) at time of implantation.
- •Has an overt infection at the time of implantation.
- •Has 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 would affect the endpoints of this protocol.
- •Has documented substance abuse issues.
- •Has 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
Individual component survivorship
时间窗: 10 years post-operative
Individual component survivorship for tibial base, femoral, and tibial insert at specified intervals out to 10 years follow-up.
次要结局
- Adverse Events and Adverse Device Effects(10 years post-operative)
- Patient Reported Outcomes- Questionnaires(10 years post-operative)
- Incidence of component revision(10 years post-operative)
- Radiolucencies(10 years post-operative)
研究者
研究点 (1)
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