Survivorship of Attune Primary Total Knee Prosthesis (NCT01754363) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Survivorship of Attune Primary Total Knee Prosthesis
United States, Australia, Austria1,542 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 range
22 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying how long the Attune knee replacement implant lasts in different configurations — what does that mean for me in terms of understanding which specific version of the implant might be used in my case?
2Since this study is no longer enrolling new patients but is still actively following people already in it, is there any published or interim data on how well the Attune implant has been surviving so far that you could share with me?
3How does the survivorship data from a study like this compare to what's known about other knee replacement implants I might be eligible for, and would a different implant potentially be a better fit for my situation?
4Given that this trial is focused on noninflammatory degenerative joint disease — which sounds like it may match my diagnosis — are there differences in how well knee replacements tend to perform depending on the underlying cause of my joint disease?
5Before considering a newer implant being studied for long-term survivorship, should I first explore whether I've exhausted non-surgical options, or is my condition at a stage where surgery is clearly the right next step?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.