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Active Not Recruiting NCT01754363

Survivorship of Attune Primary Total Knee Prosthesis

Conditions: Noninflammatory Degenerative Joint Disease

Sex: All
Ages: 22 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 1542
Sponsor: DePuy International

Location: Mayo Clinic Arizona Scottsdale Arizona

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.

Eligibility Criteria

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 product in the last three months. * Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims. * Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires. * Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication. * Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease). * Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis, etc.). * Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the protocol. * Subject has a medical condition with less than 5 years of life expectancy.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT01754363). StuddyBuddy aggregates publicly available trial information.