ATTUNE Revision System in the Revision Total Knee Arthroplasty Population
NCT ID: NCT03153475
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
400 participants
INTERVENTIONAL
2017-05-30
2029-03-31
Brief Summary
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Detailed Description
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The primary endpoint of survivorship at 5 years was selected to capture the time period during which the majority of revision failures occur while providing a good indication of long term survivorship. The secondary outcomes include commonly used measures of clinical performance that will allow for comparison with published literature. Additionally, patient reported outcomes, AORI bone defect classification , satisfaction and pain scores will be collected and analyzed.
Male and female Subjects, age 22-80 years, inclusive, with a failed primary knee arthroplasty, including unicompartmental or failed previous revision TKA, who are suitable candidates for revision TKA using the ATTUNE® Revision system are eligible for enrollment in this study. The use of the ATTUNE Revision system includes both partial and complete revision surgical procedures, including implantation of revision components as the second stage within a two-stage treatment for infection.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ATTUNE Revision Knee System
The ATTUNE Revision system is complementary to the ATTUNE primary knee portfolio and includes both rotating platform (RP) and fixed bearing (FB) configurations. The system includes a full compliment of implants designed to address the challenges faced in revision knee surgeries. These implants include Stemmable tibial and femoral components, augments, sleeves and offsets
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
22 Years
80 Years
ALL
No
Sponsors
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DePuy Orthopaedics
INDUSTRY
Responsible Party
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Principal Investigators
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Sukhjeet Kaur
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Scripps Clinic Torrey Pines
San Diego, California, United States
Colorado Joint Replacement
Denver, Colorado, United States
Orthopaedic Center of the Rockies
Fort Collins, Colorado, United States
Orthopedic Partners
Niantic, Connecticut, United States
Florida Orthopedic Associates
DeLand, Florida, United States
Arthroplasty Foundation
Louisville, Kentucky, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Mery Hospital
Ozark, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Rothman Institute
Egg Harbor, New Jersey, United States
UNC Orthopaedics
Chapel Hill, North Carolina, United States
OrthoCarolina Hip and Knee Center
Charlotte, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Southern Joint Replacement Institute
Nashville, Tennessee, United States
Texas Institute for Hip & Knee Surgery
Austin, Texas, United States
Fondren Orthopedic Group
Houston, Texas, United States
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, Canada
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
Countries
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Other Identifiers
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DSJ-2016-02
Identifier Type: -
Identifier Source: org_study_id