ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population

Last updated: April 1, 2025
Sponsor: DePuy Orthopaedics
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

ATTUNE Revision Knee System in Total Knee Arthroplasty

Clinical Study ID

NCT03153449
DSJ-2016-03
  • Ages 22-80
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Subject is male or female and between the ages of 22 and 80 years at the time ofconsent, inclusive.

  2. The decision to have knee replacement with the study device is regardless of theresearch.

  3. The devices are to be used according to the approved indications.

  4. Subject that is willing to give voluntary, written informed consent to participatein this clinical investigation and authorize the transfer of his/her information tothe Sponsor

  5. Subject is currently not bedridden.

  6. Subject, in the opinion of the Investigator, is able to understand this clinicalinvestigation and is willing and able to perform all study procedures and follow-upvisits and co-operate with investigational procedures.

  7. Subject is able to read, and comprehend the Informed Consent Document as well ascomplete 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

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 Investigatorplans to treat a potential study subject with either simultaneous (two (2) knees inone (1) surgical setting) or staged bilateral TKA, then this subject may beenrolled; however, only the first knee may be enrolled into this study.

  3. Subject had a contralateral amputation.

  4. Previous partial knee replacement (unicompartmental, bicompartmental orpatellofemoral joint replacement) or primary TKA in affected knee.

  5. Subject is currently diagnosed with radicular pain from the spine that radiates intothe 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 orworker's compensation claims.

  8. Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in thelast 5 years) or has a psychological disorder that could affect his/her ability tocomplete patient reported questionnaires or be compliant with follow-uprequirements.

  9. Subject was diagnosed and is taking prescription medications to treat a musculardisorder that limits mobility due to severe stiffness and pain such as fibromyalgiaor polymyalgia.

  10. Subject has a significant neurological or musculoskeletal disorder(s) or diseasethat may adversely affect gait or weight bearing activities (e.g., musculardystrophy, multiple sclerosis, Charcot disease).

  11. Subject has a medical condition with less than five (5) years life expectancy asdetermined by the Investigator.

  12. Subject has been diagnosed with an inflammatory arthritis (including uncontrolledgout, rheumatoid, psoriatic etc.).

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: ATTUNE Revision Knee System in Total Knee Arthroplasty
Phase:
Study Start date:
September 19, 2017
Estimated Completion Date:
June 30, 2028

Study Description

Within primary TKA, there are factors that lead to more complex procedures that include patients with high BMIs, advanced preoperative deformities and ligamentous laxity. Such cases may require the surgeon to treat using ancillary components, such as stems and/or augments and/or additional constraint.

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.

Connect with a study center

  • Finders Private Hospital

    Adelaide,
    Australia

    Site Not Available

  • St. John of God Murdoch Hospital

    Perth,
    Australia

    Active - Recruiting

  • Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.

    Linz,
    Austria

    Active - Recruiting

  • MoRe Foundation

    Antwerp,
    Belgium

    Site Not Available

  • London Health Sciences Centre University Hospital

    London, Ontario
    Canada

    Terminated

  • Concordia Joint Replacement

    Winnipeg,
    Canada

    Terminated

  • Centre Hospitalier Universitaire de Rennes

    Rennes,
    France

    Active - Recruiting

  • Klinik und Poliklinik für Orthopädie und Sportorthopädie am Klinikum rechts der Isar der Technischen Universität Münche

    Munich,
    Germany

    Active - Recruiting

  • Asklepios Orthopädische Klinik Lindenlohe

    Schwandorf,
    Germany

    Active - Recruiting

  • South Infirmary Public Hospital

    Cork,
    Ireland

    Active - Recruiting

  • Ospedale Sacro Cuore

    Verona,
    Italy

    Site Not Available

  • University Hospital Maastricht

    Maastricht,
    Netherlands

    Active - Recruiting

  • Wellington Hospital

    Wellington,
    New Zealand

    Active - Recruiting

  • Kantonsspital Baselland (Bruderholz, Liestal, Laufen), Department of Orthopaedic Surgery and Traumatology

    Basel,
    Switzerland

    Site Not Available

  • Hampshire Hospitals NHS Foundation Trust

    Basingstoke,
    United Kingdom

    Active - Recruiting

  • Victoria Hospital NHS Fife

    Kirkcaldy,
    United Kingdom

    Active - Recruiting

  • Chapel Allerton Orthopaedic Centre

    Leeds,
    United Kingdom

    Active - Recruiting

  • James Cook University Hospital

    Middlesbrough,
    United Kingdom

    Active - Recruiting

  • James Cook University Hospital

    North Yorkshire,
    United Kingdom

    Site Not Available

  • The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

    Oswestry,
    United Kingdom

    Active - Recruiting

  • Nuffield Orthopaedic Centre

    Oxford,
    United Kingdom

    Active - Recruiting

  • Wrightington Hospital

    Wigan,
    United Kingdom

    Active - Recruiting

  • Scripps Clinic Torrey Pines

    San Diego, California 92037
    United States

    Active - Recruiting

  • Colorado Joint Replacement

    Denver, Colorado 80210
    United States

    Active - Recruiting

  • Orthopaedic Center of the Rockies

    Fort Collins, Colorado 80525
    United States

    Active - Recruiting

  • Orthopedic Partners

    Niantic, Connecticut 06357
    United States

    Active - Recruiting

  • Florida Orthopedic Associates

    DeLand, Florida 32720
    United States

    Active - Recruiting

  • Arthroplasty Foundation

    Louisville, Kentucky 40215
    United States

    Terminated

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

  • Mery Hospital

    Ozark, Missouri 65721
    United States

    Active - Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Active - Recruiting

  • Rothman Institute

    Egg Harbor Township, New Jersey 08234
    United States

    Active - Recruiting

  • UNC Orthopaedics

    Chapel Hill, North Carolina 27514
    United States

    Terminated

  • OrthoCarolina Hip and Knee Center

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Southern Joint Replacement Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Texas Institute for Hip & Knee Surgery

    Austin, Texas 78751
    United States

    Active - Recruiting

  • Fondren Orthopedic Group

    Houston, Texas 77030
    United States

    Active - Recruiting

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