Survivorship of Attune Primary Total Knee Prosthesis (NCT01754363) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Survivorship of Attune Primary Total Knee Prosthesis
United States1,542 participantsStarted 2013-02-01
Plain-language summary
This post-marketing investigation will evaluate the long term (up to 15 years) survivorship of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint disease. Data from Subjects who receive one of four knee configurations will be pooled to establish a contemporary dataset.
Who can participate
Age range22 Years – 75 Years
SexALL
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Inclusion Criteria:
* Subject is male or female and between the ages of 22 and 75 years at the time of surgery, inclusive.
* Subject was diagnosed with NIDJD.
* Subject is a suitable candidate for cemented primary total knee arthroplasty using the devices described in this protocol with either resurfaced or non-resurfaced patellae.
* Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy.
* Subject is currently not bedridden.
* Subject in the opinion of the Clinical Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedure and follow-up visits and co-operate with investigational procedures.
* Subject must be comfortable with speaking, reading and understanding questions and providing responses in an available translated language for the PROs in the protocol.
* The devices specified in this protocol were implanted.
Exclusion Criteria:
* Subject is a woman who is pregnant or lactating.
* Contralateral knee has already been enrolled in this study.
* Subject had a contralateral amputation.
* Previous partial knee replacement (unilateral, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
* Subject is currently experiencing radicular pain from the spine.
* Subject has participated in an IDE/IND clinical investigation with an investigational…