ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population

Running, not enrolling · Not applicable

Conditions studied: Primary 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 complex primary total knee arthroplasty.

Key facts

Study ID

NCT03153449

Run by

DePuy Orthopaedics

People needed

400

Starts

2017-09-19

Expected to finish

2030-10-17

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.
• The decision to have knee replacement with the study device is regardless of the research.
• The devices are to be used according to the approved indications.
• 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.
• Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.
• 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.
• Subject has not been diagnosed with an inflammatory arthritis (including gout, rheumatoid, psoriatic etc.)

You may not qualify if…

• The Subject is a woman who is pregnant or lactating.
• Contralateral knee has already been enrolled in this study. If the Investigator plans to treat a potential study subject with either simultaneous (two (2) knees in one (1) surgical setting) or staged bilateral TKA, then this subject may be enrolled; however, only the first knee may be enrolled into this study.
• Subject had a contralateral amputation.
• Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement) or primary TKA in affected knee.
• Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.
• 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.
• Subject has been diagnosed with an inflammatory arthritis (including uncontrolled gout, rheumatoid, psoriatic etc.).

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
• 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
• Fremantle Hospital — Fremantle, Australia
• St. John of God Murdoch Hospital — Perth, Australia
• Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H. — Linz, Austria
• 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
• Asklepios Orthopädische Klinik Lindenlohe — Schwandorf in Bayern, Germany
• South Infirmary Public Hospital — Cork, Ireland

Full record on ClinicalTrials.gov

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