Phase
Condition
N/ATreatment
ATTUNE Revision Knee System in Total Knee Arthroplasty
Clinical Study ID
Ages 22-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is male or female and between the ages of 22 and 80 years at the time ofconsent, inclusive.
The decision to have knee replacement with the study device is regardless of theresearch.
The devices are to be used according to the approved indications.
Subject that is willing to give voluntary, written informed consent to participatein this clinical investigation and authorize the transfer of his/her information tothe Sponsor
Subject is currently not bedridden.
Subject, in the opinion of the Investigator, is able to understand this clinicalinvestigation and is willing and able to perform all study procedures and follow-upvisits and co-operate with investigational procedures.
Subject is able to read, and comprehend the Informed Consent Document as well ascomplete 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.)
Exclusion
Exclusion Criteria:
The Subject is a woman who is pregnant or lactating.
Contralateral knee has already been enrolled in this study. If the Investigatorplans to treat a potential study subject with either simultaneous (two (2) knees inone (1) surgical setting) or staged bilateral TKA, then this subject may beenrolled; however, only the first knee may be enrolled into this study.
Subject had a contralateral amputation.
Previous partial knee replacement (unicompartmental, bicompartmental orpatellofemoral joint replacement) or primary TKA in affected knee.
Subject is currently diagnosed with radicular pain from the spine that radiates intothe 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 orworker's compensation claims.
Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in thelast 5 years) or has a psychological disorder that could affect his/her ability tocomplete patient reported questionnaires or be compliant with follow-uprequirements.
Subject was diagnosed and is taking prescription medications to treat a musculardisorder that limits mobility due to severe stiffness and pain such as fibromyalgiaor polymyalgia.
Subject has a significant neurological or musculoskeletal disorder(s) or diseasethat may adversely affect gait or weight bearing activities (e.g., musculardystrophy, multiple sclerosis, Charcot disease).
Subject has a medical condition with less than five (5) years life expectancy asdetermined by the Investigator.
Subject has been diagnosed with an inflammatory arthritis (including uncontrolledgout, rheumatoid, psoriatic etc.).
Study Design
Study Description
Connect with a study center
Finders Private Hospital
Adelaide,
AustraliaSite Not Available
St. John of God Murdoch Hospital
Perth,
AustraliaActive - Recruiting
Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
Linz,
AustriaActive - Recruiting
MoRe Foundation
Antwerp,
BelgiumSite Not Available
London Health Sciences Centre University Hospital
London, Ontario
CanadaTerminated
Concordia Joint Replacement
Winnipeg,
CanadaTerminated
Centre Hospitalier Universitaire de Rennes
Rennes,
FranceActive - Recruiting
Klinik und Poliklinik für Orthopädie und Sportorthopädie am Klinikum rechts der Isar der Technischen Universität Münche
Munich,
GermanyActive - Recruiting
Asklepios Orthopädische Klinik Lindenlohe
Schwandorf,
GermanyActive - Recruiting
South Infirmary Public Hospital
Cork,
IrelandActive - Recruiting
Ospedale Sacro Cuore
Verona,
ItalySite Not Available
University Hospital Maastricht
Maastricht,
NetherlandsActive - Recruiting
Wellington Hospital
Wellington,
New ZealandActive - Recruiting
Kantonsspital Baselland (Bruderholz, Liestal, Laufen), Department of Orthopaedic Surgery and Traumatology
Basel,
SwitzerlandSite Not Available
Hampshire Hospitals NHS Foundation Trust
Basingstoke,
United KingdomActive - Recruiting
Victoria Hospital NHS Fife
Kirkcaldy,
United KingdomActive - Recruiting
Chapel Allerton Orthopaedic Centre
Leeds,
United KingdomActive - Recruiting
James Cook University Hospital
Middlesbrough,
United KingdomActive - Recruiting
James Cook University Hospital
North Yorkshire,
United KingdomSite Not Available
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry,
United KingdomActive - Recruiting
Nuffield Orthopaedic Centre
Oxford,
United KingdomActive - Recruiting
Wrightington Hospital
Wigan,
United KingdomActive - Recruiting
Scripps Clinic Torrey Pines
San Diego, California 92037
United StatesActive - Recruiting
Colorado Joint Replacement
Denver, Colorado 80210
United StatesActive - Recruiting
Orthopaedic Center of the Rockies
Fort Collins, Colorado 80525
United StatesActive - Recruiting
Orthopedic Partners
Niantic, Connecticut 06357
United StatesActive - Recruiting
Florida Orthopedic Associates
DeLand, Florida 32720
United StatesActive - Recruiting
Arthroplasty Foundation
Louisville, Kentucky 40215
United StatesTerminated
University of Mississippi Medical Center
Jackson, Mississippi 39216
United StatesActive - Recruiting
Mery Hospital
Ozark, Missouri 65721
United StatesActive - Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
United StatesActive - Recruiting
Rothman Institute
Egg Harbor Township, New Jersey 08234
United StatesActive - Recruiting
UNC Orthopaedics
Chapel Hill, North Carolina 27514
United StatesTerminated
OrthoCarolina Hip and Knee Center
Charlotte, North Carolina 28207
United StatesActive - Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United StatesActive - Recruiting
Southern Joint Replacement Institute
Nashville, Tennessee 37203
United StatesActive - Recruiting
Texas Institute for Hip & Knee Surgery
Austin, Texas 78751
United StatesActive - Recruiting
Fondren Orthopedic Group
Houston, Texas 77030
United StatesActive - Recruiting
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