ATTUNE Revision System in the Revision Total Knee Arthroplasty Population (NCT03153475) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
ATTUNE Revision System in the Revision Total Knee Arthroplasty Population
United States, Australia, Austria400 participantsStarted 2017-05-30
Plain-language summary
Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in revision total knee arthroplasty.
Who can participate
Age range
22 Years – 80 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 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.
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.
1Since this study is no longer enrolling new patients, can you tell me if there are any similar studies looking at revision knee replacement implants that I might still be able to participate in?
2This trial is measuring 'survivorship' of the ATTUNE Revision System — meaning how long the implant lasts without needing another surgery — so can you help me understand what the early data suggests about how durable this implant has been compared to other revision knee replacement options?
3Since this is listed as 'Phase NA,' which typically means it's a real-world device study rather than an experimental drug trial, can you explain what that means for what we know — and don't yet know — about the safety and performance of the ATTUNE Revision System?
4Given that this trial specifically focuses on revision total knee replacement, which is already a more complex surgery than a first-time knee replacement, can you walk me through what additional risks I should be aware of compared to a standard knee replacement?
5Is the ATTUNE Revision System the implant you would recommend for my specific situation, or are there other revision implant systems with longer track records that might be worth considering first?
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.
. 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.