Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Revision Total Knee Arthroplasty - DSJ-2016-02: Attune revision

Cturn0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年7月22日

适应症

试验速览

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•* Subject is male or female and between the ages of 22 and 80 years at the time
•of consent, inclusive.
•* Subject presents with a primary knee arthroplasty (primary TKA,
•unicompartmental) or prior revision TKA that requires a revision procedure of
•implanted tibial and/or femoral components.
•* The decision to perform a knee revision with the study device is regardless
•of the research.
•* 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
•* Subject is currently not bedridden
•* The devices are to be used according to the approved indications.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.

•* The Subject is a woman who is pregnant or lactating.
•* Contralateral knee has already been enrolled in this study.
•* Subject had a contralateral amputation.
•* Subject is currently diagnosed with radicular pain from the spine that
•radiates into the limb to receive RTKA.
•* Subject has participated in a clinical investigation with an investigational
•product (drug or device) in the last three (3) months.
•* Subject is currently involved in any personal injury litigation,
•medical-legal or worker's compensation claims.
•* 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.
•* 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.
•* 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).
•* Subject has a medical condition with less than five (5) years life expectancy
•as determined by the Investigator.
•* Uncontrolled gout

发起方

Cturn