Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Complex Primary Total Knee Arthroplasty - DSJ-2016-03: Attune Complex

Cturn0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月15日

试验速览

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•a) Subject is male or female and between the ages of 22 and 80 years at the
•time of consent, inclusive.
•b) The decision to have knee replacement with the study device is regardless of
•the research.
•c) The devices are to be used according to the approved indications.
•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 PROMs in either
•English or one of the available translations.
•h) Subject has not been diagnosed with an inflammatory arthritis (including
•gout, rheumatoid, psoriatic etc.)

•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) 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 his/her
•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 activities (e.g.,
•muscular dystrophy, multiple sclerosis, Charcot disease).

发起方

Cturn