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Clinical Trials in the USA / NCT03153449
Active, not recruiting Not applicable

ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population

NCT03153449 · tracked via the Priya Life Science USA tracker
Sponsor
DePuy Orthopaedics
Phase
Not applicable
Started
2017-09-19
Last updated
2026-08-28

Condition(s) studied

Primary Knee Arthroplasty

Investigational drug(s) / intervention(s)

ATTUNE Revision Knee System in Total Knee Arthroplasty

ATTUNE Revision Knee System in Total Knee Arthroplasty: Implants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their anatomy is such that the use of revision components are required to perform primary total knee arthroplasty

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 complex primary 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. The decision to have knee replacement with the study device is regardless of the research. 3. The devices are to be used according to the approved indications. 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. 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. 7. 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. 8. Subject has not been diagnosed with an inflammatory arthritis (including gout, rheumatoid, psoriatic etc.) Exclusion Criteria: 1. The Subject is a woman who is pregnant or lactating. 2. Contralateral knee has already been enrolled in this study. If the Investigator plans to treat a potential study subject with either simultaneous (two (2) knees in one (1) surgical setting) or staged bilateral TKA, then this subject may be enrolled; however, only the first knee may be enrolled into this study. 3. Subject had a contralateral amputation. 4. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement) or primary TKA in affected knee. 5. Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA. 6. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months. 7. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims. 8. 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. 9. 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. 10. 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). 11. Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator. 12. Subject has been diagnosed with an inflammatory arthritis (including uncontrolled gout, rheumatoid, psoriatic etc.). \-

Primary outcome measure(s)

Trial sites (34)

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
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
Fremantle Hospital Fremantle Australia
St. John of God Murdoch Hospital Perth Australia
Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H. Linz Austria
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
University Hospital Maastricht Maastricht Netherlands
Wellington Hospital Wellington New Zealand
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 Middlesbrough 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

More DePuy Orthopaedics trials in the USA

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 NCT03153449 on ClinicalTrials.gov ↗ ← All trials in the USA