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14022 ATTUNE Cementless RP Clinical Performance Evaluation
Sponsor: DePuy Orthopaedics
Summary
The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).
Official title: Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty
Key Details
Gender
All
Age Range
22 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
540
Start Date
2016-09-01
Completion Date
2027-09-01
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Cementless Total Knee Arthroplasty
Patients will undergo a primary total knee replacement using one of the two configurations of the ATTUNE Cementless knee (CR RP or PS RP)
Locations (20)
Colorado Joint Replacement
Denver, Colorado, United States
Florida Research Associates
DeLand, Florida, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
New London Hospital
New London, New Hampshire, United States
Rothman Institute
Egg Harbor, New Jersey, United States
SUNY downstate Medical Center
Brooklyn, New York, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Associated Orthopaedics of Kingsport
Kingsport, Tennessee, United States
Texas Tech University Heath Science Center
Lubbock, Texas, United States
Hampton Roads Orthopaedics and Sports Medicine
Newport News, Virginia, United States
Krankenhaus der Barmherzigen Schwestern Ried im Innkreis
Ried im Innkreis, Upper Austria, Austria
Foothills Medical Centre, University of Calgary
Calgary, Alberta, Canada
CHU de la Cavale Blanche
Brest, Cedex, France
Sevice de Chirurgie Orthoedique et Traumatologique
Salouël, France
Klinikum Garmisch-Partenkirchen GmbH
Garmisch-Partenkirchen, Germany
South Infirmary Victoria University Hospital
Cork, Ireland
Elkerliek Ziekenhuis
Helmond, North Brabant, Netherlands
University of Otago
Christchurch, New Zealand
Wrightington Hospital
Wigan, Lancashire, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom