Post Market Clinical Follow-Up Study for EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Component Survivorship of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia
研究概览
简要总结
MicroPort Orthopedics Inc. (MPO) plans to market the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert globally, including in the European Union (EU). MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® NitrX™ CS/CR Non-Porous Femur. These components are used along with the EVOLUTION® Cruciate Sacrificing (CS) Tibial Insert components that is marketed in the European Union (EU). This type of data collection is required by regulatory authorities for all TKA devices that do not have medium to long-term clinical evidence available.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 determined to undergo a primary TKA with the specified combination of components: EVOLUTION® NitrX™ CS/CR Non-Porous Femur, EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® CS Tibial Insert
- •Has previously undergone or currently has determined to undergo a 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;
- •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.
- •Previously implanted subjects must be enrolled within 14 months of their primary TKA implantation.
- •Prospective enrollment of a previously unimplanted contralateral knee is permitted in this study provided:
- •the specified combination of components (EVOLUTION® NitrX™ CS/CR Non-Porous Femur, EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® CS Tibial Insert) are used,
- •all other aspects of the Inclusion/Exclusion Criteria are satisfied,
- •enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
- •the subject agrees to a second Informed Consent document and data collection specific to the second TKA.
- •Bilateral subjects can have both TKAs enrolled in the study provided:
- •the specified combination of components (EVOLUTION® NitrX™ CS/CR Non-Porous Femur, EVOLUTION® NitrX™ Non-Porous Keeled Tibia and EVOLUTION® CS Tibial Insert) were implanted in both,
- •all other aspects of the Inclusion/Exclusion Criteria are satisfied,
- •enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
- •the subject agrees to a second Informed Consent document and data collection specific to the second TKA.
- •Bilateral implantation can occur at different time periods for the same subject.
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 a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
- •Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram 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 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
Component Survivorship of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia
时间窗: 10 years post-operative
The primary endpoint is to evaluate component survivorship of the EVOLUTION® NitrX™ Non-Porous Keeled Tibia out to 10 years follow-up. Percentage of knees survived with no revisions or replacement at 10-year
Component Survivorship of the EVOLUTION® NitrX™ CS/CR Non-Porous Femur
时间窗: 10 years post-operative
The primary endpoint is to evaluate component survivorship of the EVOLUTION® NitrX™ CS/CR Non-Porous Femur out to 10 years follow-up. Percentage of knees survived with no revisions or replacement at 10-year.
Component Survivorship of the EVOLUTION® NitrX™ MP CS tibial inserts
时间窗: 10 years post-operative
The primary endpoint is to evaluate component survivorship of the EVOLUTION® NitrX™ MP CS tibial inserts out to 10 years follow-up. Percentage of knees survived with no revisions or replacement at 10-year.
次要结局
- Subject Satisfaction(10 years post-operative)
- Functional Scores(10 years post-operative)
- Radiolucencies(10 years post-operative)
- To assess subject safety: Adverse Events(1, 3, 5, 7, 10 years)
- To assess device tolerability within subject: Adverse Events(10 years post-operative)