JPRN-UMIN000026764已完成未知
Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty In the Japanese Patient Population - DSJ-2016-07 ATTUNE Cementless CR RP Japan
Johnson & Johnson K.K. Medical Company0 个研究点目标入组 80 人开始时间: 2017年4月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 22years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Subjects will be excluded from participation in the study if they meet any of the following criteria: a) The Subject is a woman who is pregnant or lactating. b) Contralateral knee has already been enrolled in this study c) Subject had a contralateral amputation. d) Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee. e) Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA. f) Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months. g) Subject is currently involved in any personal injury litigation, medical-legal or Worker's Accident Insurance claims (similar to Workers Compensation in USA). h) Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements. i) Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia. j) Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis, Charcot disease). k) Subject is suffering from inflammatory arthritis (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.). l) Subject has a medical condition with less than two (2) years life expectancy. m) Uncontrolled gout
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