DRKS00011069已完成不适用
Post Market Clinical Follow-Up Study of the EVOLUTION® Total Knee Arthroplasty System with Cruciate Sacrificing Inserts (Project AMETHYST)
MicroPort Orthopedics Inc.USA0 个研究点目标入组 150 人开始时间: 2016年9月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 21 Years 至 one（—）
- 性别
- All
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 which could affect the endpoints of this protocol
- •- 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
研究者
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