NL-OMON50255招募中不适用
Multi-Center Clinical Evaluation of the ATTUNE® Cementless Rotating Platform Total Knee Arthroplasty - 14022 ATTUNE(R) Cementless RP Clinical Performance Evaluation
DePuy Synthes Joint Reconstruction Inc0 个研究点目标入组 65 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 65
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
- 18 至 99（—）
入选标准
- •a) Subject is male or female and between the ages of 22 and 80 years at the
- •time of consent, inclusive.
- •b) Subject was diagnosed with NIDJD and in the opinion of the Investigator,
- •their condition is consistent with the indications detailed in the Instructions
- •c) Subject, in the opinion of the Investigator, is a suitable candidate for
- •cementless primary TKA using the devices described in this CIP with either
- •resurfaced or non-resurfaced patellae.
- •d) Subject that is willing to give voluntary, written informed consent to
- •participate in this clinical investigation and authorize the transfer of
- •his/her information to the Sponsor
- •e) Subject is currently not bedridden
- •f) Subject, in the opinion of the Investigator, is able to understand this
- •clinical investigation and is willing and able to perform all study procedures
- •and follow-up visits and co-operate with investigational procedures.
- •g) Subject is able to read, and comprehend the Informed Consent Document as
- •well as complete the required PROs in either English or one of the available
- •translations.
排除标准
- •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, bicompartamental 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 compensation claims.
- •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 five (5) years life
- •expectancy.
- •m) Uncontrolled gout
研究者
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