Who is eligible for clinical trial NCT01754363?

Participants must meet protocol criteria for Noninflammatory Degenerative Joint Disease. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT01754363 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-27

Survivorship of Attune Primary Total Knee Prosthesis (NCT01754363)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: DePuy International

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (14 items).

Location: Mayo Clinic Arizona — Scottsdale, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (27 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗