Attune Primary Total Knee Replacement: Patients will undergo a primary total knee replacement using one of the four configurations of the Attune knee (CR FB, CR RP, PS FB, PS RP).
Study summary
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.
Eligibility
Sex
ALL
Min age
22 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
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.).
* 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.
Primary outcome measure(s)
Survivorship of each configuration. — Minimum 15 years (5414 - 5658 days) Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).
Trial sites (27)
Facility
City
Region
Status
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
Belgium
University of Western Ontario-Department of Orthopaedic Surgery
London
Ontario
Orthopädische Klinik für die Universität Regensburg
Bad Abbach
Bavaria
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
Seoul National University Hospital
Seoul
South Korea
Queen Mary Hospital
Dunfermline
Fife
Robert Jones & Agnes Hunt Orthopaedic Hospital
Gobowen
Oswestry
New Royal Infirmary of Edinburgh
Edinburgh
Scotland
Princess Alexandria Hospital
Harlow
United Kingdom
Clifton Park NHS Treatment Centre
York
United Kingdom
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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