Survivorship of Attune Primary Total Knee Prosthesis

Running, not enrolling · Not applicable

Conditions studied: Noninflammatory Degenerative Joint Disease

In brief

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.

Key facts

Study ID

NCT01754363

Run by

DePuy International

People needed

1542

Starts

2013-02-01

Expected to finish

2030-02-01

Last updated by the study team

2026-07-06

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 product in the last three months.
• Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
• Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires.
• Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication.
• Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
• Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis, etc.).
• Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the protocol.
• Subject has a medical condition with less than 5 years of life expectancy.

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Orthopaedic Specialty Institute — Orange, California, United States
• Florida Research Associates, LLC — DeLand, Florida, United States
• Center for Hip and Knee Surgery — Mooresville, Indiana, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• Orthopedic One — Columbus, Ohio, United States
• OrthoNeuro — New Albany, Ohio, United States
• Penn State Hershey Bone & Joint Institute — Hershey, Pennsylvania, United States
• Texas Institute for Hip and Knee Surgery, LLC — Austin, Texas, United States
• Canberra Hospital-Trauma & Orthopaedic Research Unit — Adelaide, South Australia, Australia
• Univ.-Klinik für Orthopädie — Vienna, Lower Austria, Austria
• Krankenhaus der Barmherzigen — Linz, Upper Austria, Austria
• Monica Camputs O.L.V. Middelares — Antwerp, Belgium
• University of Western Ontario-Department of Orthopaedic Surgery — London, Ontario, Canada
• Orthopädische Klinik für die Universität Regensburg — Bad Abbach, Bavaria, Germany
• UniversitatsKlinikum Heidelberg — Heidelberg, Germany
• Queen Mary Hospital — Hong Kong, Hong Kong
• University Malaya Medical Centre — Kuala Lumpur, Malaysia
• Ascot Hospital — Auckland, New Zealand
• Singapore General Hospital-Dept of Orthopaedic Surgery — Singapore, Singapore
• Seoul National University Boramae Hospital — Seoul, Dongjak-gu, South Korea
• Seoul National University Hospital — Seoul, South Korea
• Queen Mary Hospital — Dunfermline, Fife, United Kingdom
• Robert Jones & Agnes Hunt Orthopaedic Hospital — Gobowen, Oswestry, United Kingdom
• New Royal Infirmary of Edinburgh — Edinburgh, Scotland, United Kingdom

Full record on ClinicalTrials.gov

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