14022 ATTUNE Cementless RP Clinical Performance Evaluation

Running, not enrolling · Not applicable

Conditions studied: Osteoarthritis

In brief

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).

Key facts

Study ID: NCT02839850
Run by: DePuy Orthopaedics
People needed: 540
Starts: 2016-09-01
Expected to finish: 2027-09-01
Last updated by the study team: 2026-07-06

Who can join

Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive.
Subject was diagnosed with NIDJD.
Subject, in the opinion of the Investigator, is a suitable candidate for cementless primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
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
Subject is currently not bedridden
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.
Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROs in either English or one of the available translations.

You may not qualify if…

The 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 (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
Subject is currently diagnosed with radicular pain from the spine that radiates into the 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 or worker's compensation claims.
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 their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
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.
Subject has a significant neurological or musculoskeletal disorder(s) 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 erythematosus, etc.).
Subject has a medical condition with less than five (5) years life expectancy.
Uncontrolled gout

Where it is running

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

Full record on ClinicalTrials.gov

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