ATTUNE Revision Knee System in Total Knee Arthroplasty
ATTUNE Revision Knee System in Total Knee Arthroplasty: Implants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their anatomy is such that the use of revision components are required to perform primary total knee arthroplasty
Study summary
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.
Eligibility
Sex
ALL
Min age
22 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive.
2. The decision to have knee replacement with the study device is regardless of the research.
3. The devices are to be used according to the approved indications.
4. 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
5. Subject is currently not bedridden.
6. 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.
7. 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.
8. Subject has not been diagnosed with an inflammatory arthritis (including gout, rheumatoid, psoriatic etc.)
Exclusion Criteria:
1. The Subject is a woman who is pregnant or lactating.
2. 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.
3. Subject had a contralateral amputation.
4. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement) or primary TKA in affected knee.
5. Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.
6. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
7. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
8. 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.
9. 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.
10. 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).
11. Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator.
12. Subject has been diagnosed with an inflammatory arthritis (including uncontrolled gout, rheumatoid, psoriatic etc.).
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Primary outcome measure(s)
KOOS ADL — 2 Years Evaluate change from preoperative baseline to the 2 yr timepoint in patient reported functional outcome, KOOS-ADL for the ATTUNE® Revision TKA FB and RP configurations.
Trial sites (34)
Facility
City
Region
Status
Scripps Clinic Torrey Pines
San Diego
California
Colorado Joint Replacement
Denver
Colorado
Orthopaedic Center of the Rockies
Fort Collins
Colorado
Orthopedic Partners
Niantic
Connecticut
Florida Orthopedic Associates
DeLand
Florida
Arthroplasty Foundation
Louisville
Kentucky
University of Mississippi Medical Center
Jackson
Mississippi
Dartmouth-Hitchcock Medical Center
Lebanon
New Hampshire
Rothman Institute
Egg Harbor
New Jersey
UNC Orthopaedics
Chapel Hill
North Carolina
OrthoCarolina Hip and Knee Center
Charlotte
North Carolina
The Ohio State University Wexner Medical Center
Columbus
Ohio
Southern Joint Replacement Institute
Nashville
Tennessee
Texas Institute for Hip & Knee Surgery
Austin
Texas
Fondren Orthopedic Group
Houston
Texas
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
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
University Hospital Maastricht
Maastricht
Netherlands
Wellington Hospital
Wellington
New Zealand
Hampshire Hospitals NHS Foundation Trust
Basingstoke
United Kingdom
Victoria Hospital NHS Fife
Kirkcaldy
United Kingdom
Chapel Allerton Orthopaedic Centre
Leeds
United Kingdom
James Cook University Hospital
Middlesbrough
United Kingdom
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
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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