ATTUNE Revision System for Total Knee Replacement
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking prescription medications for a muscular disorder that limits mobility, you may not be eligible to participate.
Is the ATTUNE Revision System for Total Knee Replacement safe for humans?
The ATTUNE Total Knee Replacement System has been used in over 600,000 patients worldwide with generally good clinical outcomes, but there have been concerns about the cement-tibial interface, which is the area where the knee implant connects to the bone. Some studies have reported issues with early tibial tray debonding, which means the part of the implant that connects to the shinbone may come loose.12345
How is the ATTUNE Revision Knee System treatment different from other treatments for knee replacement?
What data supports the effectiveness of the ATTUNE Revision Knee System treatment?
Research shows that new revision knee systems, like the ATTUNE Revision Knee System, are designed to improve stability, function, and implant longevity in knee replacement surgeries. Studies indicate that patients generally report satisfaction with revision procedures, and new systems are believed to facilitate better outcomes.26101112
Who Is on the Research Team?
Sukhjeet Kaur
Principal Investigator
Sponsor GmbH
Are You a Good Fit for This Trial?
This trial is for men and women aged 22-80 who need a knee revision surgery after an initial or previous knee replacement. Participants must be able to consent, not bedridden, and capable of completing questionnaires in English or other available languages. Pregnant women, those with certain musculoskeletal disorders, uncontrolled gout, recent investigational product use, or life expectancy under five years are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo revision total knee arthroplasty using the ATTUNE® Revision system
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term monitoring
Participants' knee implant performance and satisfaction are evaluated over time
What Are the Treatments Tested in This Trial?
Interventions
- ATTUNE Revision Knee System
ATTUNE Revision Knee System is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
DePuy Orthopaedics
Lead Sponsor
Massimo Calafiore
DePuy Orthopaedics
Chief Executive Officer since 2023
MBA from Harvard Business School
Dr. Michael Stein
DePuy Orthopaedics
Chief Medical Officer since 2023
MD from University of Michigan