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Clinical Trials in Ireland / NCT03153475
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ATTUNE Revision System in the Revision Total Knee Arthroplasty Population

NCT03153475 · tracked via the Priya Life Science Ireland tracker
Sponsor
DePuy Orthopaedics
Phase
N/A
Started
2017-05-30
Last updated
2026-08-28

Condition(s) studied

Revision Total Knee Arthroplasty

Investigational drug(s) / intervention(s)

ATTUNE Revision Knee System in Revision Total Knee Arthroplasty

ATTUNE Revision Knee System in Revision Total Knee Arthroplasty: Implants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their existing implants need to be removed and replaced.

Study summary

Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in revision total knee arthroplasty.

Eligibility

Sex
ALL
Min age
22 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria 1. Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive. 2. Subject presents with a primary knee arthroplasty (primary TKA, unicompartmental) or prior revision TKA that requires a revision procedure of implanted tibial and/or femoral components. 3. The decision to perform a knee revision with the study device is regardless of the research. 4. 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 5. Subject is currently not bedridden 6. The devices are to be used according to the approved indications.Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROMs in either English or one of the available translations. Exclusion Criteria: 1. The Subject is a woman who is pregnant or lactating. 2. Contralateral knee has already been enrolled in this study. 3. Subject had a contralateral amputation. 4. Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive RTKA. 5. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months. 6. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims. 7. 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 his/her ability to complete patient reported questionnaires or be compliant with follow-up requirements. 8. 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. 9. Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease). 10. Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator. 11. Uncontrolled gout

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
Scripps Clinic Torrey Pines San Diego California
Colorado Joint Replacement Denver Colorado
Orthopaedic Center of the Rockies Fort Collins Colorado
Orthopedic Partners Niantic Connecticut
Florida Orthopedic Associates DeLand Florida
Arthroplasty Foundation Louisville Kentucky
University of Mississippi Medical Center Jackson Mississippi
Mery Hospital Ozark Missouri
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
Rothman Institute Egg Harbor New Jersey
UNC Orthopaedics Chapel Hill North Carolina
OrthoCarolina Hip and Knee Center Charlotte North Carolina
The Ohio State University Wexner Medical Center Columbus Ohio
Southern Joint Replacement Institute Nashville Tennessee
Texas Institute for Hip & Knee Surgery Austin Texas
Fondren Orthopedic Group Houston Texas
The Gold Coast Centre for Bone and Joint Surgery Gold Coast Australia
St. John of God Murdoch Hospital Perth Australia
Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H. Linz Austria
MoRe Foundation Antwerp Belgium
London Health Sciences Centre University Hospital London Ontario
Concordia Joint Replacement Winnipeg Canada
CHRU La Cavale Blanche Brest France
Centre Hospitalier Universitaire de Rennes Rennes France
Klinik und Poliklinik für Orthopädie und Sportorthopädie am Klinikum rechts der Isar der Technischen Universität Münche Munich Germany
Asklepios Orthopädische Klinik Lindenlohe Schwandorf in Bayern Germany
South Infirmary Public Hospital Cork Ireland
CLINICHE GAVAZZENI SPA aka Humanitas Castelli Bergamo Italy
University Hospital Maastricht Maastricht Netherlands
Wellington Hospital Wellington New Zealand
Kantonsspital Baselland (Bruderholz, Liestal, Laufen), Department of Orthopaedic Surgery and Traumatology Basel Switzerland
Hampshire Hospitals NHS Foundation Trust Basingstoke United Kingdom
Victoria Hospital NHS Fife Kirkcaldy United Kingdom
Chapel Allerton Orthopaedic Centre Leeds United Kingdom
James Cook University Hospital North Yorks United Kingdom
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust Oswestry United Kingdom
Nuffield Orthopaedic Centre Oxford United Kingdom
Wrightington Hospital Wigan United Kingdom
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 NCT03153475 on ClinicalTrials.gov ↗ ← All trials in Ireland