Short, Medium and Long Term Survivorship of Attune Primary Knee Prosthesis

Location:

Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

This study is designed as a prospective, single arm stratified, multi-centre investigation. Approximately 30 sites, worldwide, will recruit 1200 patients (1200 knees). Each study site is expected to enroll approximately 50 patients (50 knees). An additional 10 subjects per site may be recruited at sites which have Sub-Investigators participating in the study. Cohort reallocation is permitted. There is no control group. One thousand two hundred (1200) Subjects will be stratified into 4 subgroups of 300: cruciate retaining fixed bearing(CR FB), cruciate retaining rotating platform (CR RP), posterior stabilized fixed bearing (PS FB), and posterior stabilized rotating platform (PS RP). Treatment assignment in this study is not randomized. Each site will only enroll patients in one of the four knee configuration sub-groups most commonly used as their standard of care.

Who is eligible to participate?

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.

Last updated:

7/29/2014

NCT ID:

NCT01754363

IRB Number:

12-004492