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Clinical Trials in the UK / NCT02839850
Active, not recruiting Not applicable

14022 ATTUNE Cementless RP Clinical Performance Evaluation

NCT02839850 · tracked via the Priya Life Science UK tracker
Sponsor
DePuy Orthopaedics
Phase
Not applicable
Started
2016-09-01
Last updated
2026-08-28

Condition(s) studied

Osteoarthritis

Investigational drug(s) / intervention(s)

Cementless Total Knee Arthroplasty

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)

Study 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).

Eligibility

Sex
ALL
Min age
22 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
Colorado Joint Replacement Denver Colorado
Florida Research Associates DeLand Florida
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
New London Hospital New London New Hampshire
Rothman Institute Egg Harbor New Jersey
SUNY downstate Medical Center Brooklyn New York
UNC Chapel Hill Chapel Hill North Carolina
Associated Orthopaedics of Kingsport Kingsport Tennessee
Texas Tech University Heath Science Center Lubbock Texas
Hampton Roads Orthopaedics and Sports Medicine Newport News Virginia
Krankenhaus der Barmherzigen Schwestern Ried im Innkreis Ried im Innkreis Upper Austria
Foothills Medical Centre, University of Calgary Calgary Alberta
CHU de la Cavale Blanche Brest Cedex
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
University of Otago Christchurch New Zealand
Wrightington Hospital Wigan Lancashire
Nottingham University Hospitals NHS Trust Nottingham United Kingdom

More DePuy Orthopaedics trials in the UK

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Official registry record

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.

View NCT02839850 on ClinicalTrials.gov ↗ ← All trials in the UK