ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
NCT ID: NCT03153449
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
2017-09-19
2028-06-30
Brief Summary
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Detailed Description
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This post-market study will evaluate the short/medium term clinical performance and medium term survivorship of the ATTUNE Revision system system, which includes instrumentation, in complex primary TKA. The study is designed as a worldwide non-comparative, multi-center study with each site initially having a cohort of approximately 20 Subjects to recruit. The study will enroll approximately 200 fixed bearing and approximately 200 rotating platform configurations.
The 2-year KOOS-ADL (activities of daily living) was selected as the primary endpoint because it will evaluate the post-operative period during which outcomes typically plateau and will therefore provide a good indication of longer term outcomes
Male and female Subjects, age 22-80 years, inclusive, who require a primary knee arthroplasty in a joint that, due to deformity, instability, bone loss etc., necessitates the use of implants found within the ATTUNE Revision knee system and are suitable candidates for TKA using the ATTUNE® Revision system are eligible for enrollment in this study.
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 knees 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 complex primary knee surgeries. These implants include Stemmable tibial and femoral components, augments, sleeves and offsets
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.).
\-
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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Grant Jamgochian
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
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
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, 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
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
Countries
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Other Identifiers
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DSJ-2016-03
Identifier Type: -
Identifier Source: org_study_id