Phase
Condition
Holoprosencephaly
Birth Defects
Joint Injuries
Treatment
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
Fremantle Hospital
Fremantle 2071223,
AustraliaSite Not Available
St. John of God Murdoch Hospital
Perth,
AustraliaSite Not Available
St. John of God Murdoch Hospital
Perth 2063523,
AustraliaSite Not Available
Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
Linz,
AustriaSite Not Available
Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
Linz 2772400,
AustriaSite Not Available
MoRe Foundation
Antwerp,
BelgiumSite Not Available
London Health Sciences Centre University Hospital
London, Ontario
CanadaSite Not Available
London Health Sciences Centre University Hospital
London 6058560, Ontario 6093943
CanadaSite Not Available
Concordia Joint Replacement
Winnipeg,
CanadaSite Not Available
Concordia Joint Replacement
Winnipeg 6183235,
CanadaSite Not Available
CHRU La Cavale Blanche
Brest 3030300,
FranceSite Not Available
Centre Hospitalier Universitaire de Rennes
Rennes,
FranceSite Not Available
Centre Hospitalier Universitaire de Rennes
Rennes 2983990,
FranceSite Not Available
Klinik und Poliklinik für Orthopädie und Sportorthopädie am Klinikum rechts der Isar der Technischen Universität Münche
Munich,
GermanySite Not Available
Klinik und Poliklinik für Orthopädie und Sportorthopädie am Klinikum rechts der Isar der Technischen Universität Münche
Munich 2867714,
GermanySite Not Available
Asklepios Orthopädische Klinik Lindenlohe
Schwandorf,
GermanySite Not Available
Asklepios Orthopädische Klinik Lindenlohe
Schwandorf in Bayern 2835297,
GermanySite Not Available
South Infirmary Public Hospital
Cork,
IrelandSite Not Available
South Infirmary Public Hospital
Cork 2965140,
IrelandSite Not Available
Ospedale Sacro Cuore
Verona,
ItalySite Not Available
University Hospital Maastricht
Maastricht,
NetherlandsSite Not Available
University Hospital Maastricht
Maastricht 2751283,
NetherlandsSite Not Available
Wellington Hospital
Wellington,
New ZealandSite Not Available
Wellington Hospital
Wellington 2179537,
New ZealandSite Not Available
Kantonsspital Baselland (Bruderholz, Liestal, Laufen), Department of Orthopaedic Surgery and Traumatology
Basel,
SwitzerlandSite Not Available
Hampshire Hospitals NHS Foundation Trust
Basingstoke,
United KingdomSite Not Available
Hampshire Hospitals NHS Foundation Trust
Basingstoke 2656192,
United KingdomSite Not Available
Victoria Hospital NHS Fife
Kirkcaldy,
United KingdomSite Not Available
Victoria Hospital NHS Fife
Kirkcaldy 2645298,
United KingdomSite Not Available
Chapel Allerton Orthopaedic Centre
Leeds,
United KingdomSite Not Available
Chapel Allerton Orthopaedic Centre
Leeds 2644688,
United KingdomSite Not Available
James Cook University Hospital
Middlesbrough,
United KingdomSite Not Available
James Cook University Hospital
Middlesbrough 2642607,
United KingdomSite Not Available
James Cook University Hospital
North Yorkshire,
United KingdomSite Not Available
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry,
United KingdomSite Not Available
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry 2640861,
United KingdomSite Not Available
Nuffield Orthopaedic Centre
Oxford,
United KingdomSite Not Available
Nuffield Orthopaedic Centre
Oxford 2640729,
United KingdomSite Not Available
Wrightington Hospital
Wigan,
United KingdomSite Not Available
Wrightington Hospital
Wigan 2633948,
United KingdomSite Not Available
Scripps Clinic Torrey Pines
San Diego, California 92037
United StatesSite Not Available
Scripps Clinic Torrey Pines
San Diego 5391811, California 5332921 92037
United StatesSite Not Available
Colorado Joint Replacement
Denver, Colorado 80210
United StatesSite Not Available
Orthopaedic Center of the Rockies
Fort Collins, Colorado 80525
United StatesSite Not Available
Colorado Joint Replacement
Denver 5419384, Colorado 5417618 80210
United StatesSite Not Available
Orthopaedic Center of the Rockies
Fort Collins 5577147, Colorado 5417618 80525
United StatesSite Not Available
Orthopedic Partners
Niantic, Connecticut 06357
United StatesSite Not Available
Orthopedic Partners
Niantic 4839521, Connecticut 4831725 06357
United StatesSite Not Available
Florida Orthopedic Associates
DeLand, Florida 32720
United StatesSite Not Available
Florida Orthopedic Associates
DeLand 4152890, Florida 4155751 32720
United StatesSite Not Available
Arthroplasty Foundation
Louisville, Kentucky 40215
United StatesSite Not Available
Arthroplasty Foundation
Louisville 4299276, Kentucky 6254925 40215
United StatesSite Not Available
University of Mississippi Medical Center
Jackson, Mississippi 39216
United StatesSite Not Available
University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296 39216
United StatesSite Not Available
Mery Hospital
Ozark, Missouri 65721
United StatesSite Not Available
Mery Hospital
Ozark 4402245, Missouri 4398678 65721
United StatesSite Not Available
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
United StatesSite Not Available
Dartmouth-Hitchcock Medical Center
Lebanon 5088597, New Hampshire 5090174 03756
United StatesSite Not Available
Rothman Institute
Egg Harbor Township, New Jersey 08234
United StatesSite Not Available
Rothman Institute
Egg Harbor 8766331, New Jersey 5101760 08234
United StatesSite Not Available
UNC Orthopaedics
Chapel Hill, North Carolina 27514
United StatesSite Not Available
OrthoCarolina Hip and Knee Center
Charlotte, North Carolina 28207
United StatesSite Not Available
UNC Orthopaedics
Chapel Hill 4460162, North Carolina 4482348 27514
United StatesSite Not Available
OrthoCarolina Hip and Knee Center
Charlotte 4460243, North Carolina 4482348 28207
United StatesSite Not Available
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
The Ohio State University Wexner Medical Center
Columbus 4509177, Ohio 5165418 43210
United StatesSite Not Available
Southern Joint Replacement Institute
Nashville, Tennessee 37203
United StatesSite Not Available
Southern Joint Replacement Institute
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
Texas Institute for Hip & Knee Surgery
Austin, Texas 78751
United StatesSite Not Available
Fondren Orthopedic Group
Houston, Texas 77030
United StatesSite Not Available
Texas Institute for Hip & Knee Surgery
Austin 4671654, Texas 4736286 78751
United StatesSite Not Available
Fondren Orthopedic Group
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available

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