ATTUNE Revision System in the Revision Total Knee Arthroplasty Population

Running, not enrolling · Not applicable

Conditions studied: Revision Total Knee Arthroplasty

In brief

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.

Key facts

Study ID

NCT03153475

Run by

DePuy Orthopaedics

People needed

400

Starts

2017-05-30

Expected to finish

2029-03-31

Last updated by the study team

2026-07-06

Who can join

Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
• Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator.
• Uncontrolled gout

Where it is running

• Scripps Clinic Torrey Pines — San Diego, California, United States
• Colorado Joint Replacement — Denver, Colorado, United States
• Orthopaedic Center of the Rockies — Fort Collins, Colorado, United States
• Orthopedic Partners — Niantic, Connecticut, United States
• Florida Orthopedic Associates — DeLand, Florida, United States
• Arthroplasty Foundation — Louisville, Kentucky, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Mery Hospital — Ozark, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Rothman Institute — Egg Harbor, New Jersey, United States
• UNC Orthopaedics — Chapel Hill, North Carolina, United States
• OrthoCarolina Hip and Knee Center — Charlotte, North Carolina, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Southern Joint Replacement Institute — Nashville, Tennessee, United States
• Texas Institute for Hip & Knee Surgery — Austin, Texas, United States
• Fondren Orthopedic Group — Houston, Texas, United States
• The Gold Coast Centre for Bone and Joint Surgery — Gold Coast, Australia
• St. John of God Murdoch Hospital — Perth, Australia
• Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H. — Linz, Austria
• MoRe Foundation — Antwerp, Belgium
• London Health Sciences Centre University Hospital — London, Ontario, Canada
• Concordia Joint Replacement — Winnipeg, Canada
• CHRU La Cavale Blanche — Brest, France
• Centre Hospitalier Universitaire de Rennes — Rennes, France
• Klinik und Poliklinik für Orthopädie und Sportorthopädie am Klinikum rechts der Isar der Technischen Universität Münche — Munich, Germany

Full record on ClinicalTrials.gov

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