ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population

NCT03153449 | Active Not Recruiting FDA Device

• 1 other identifier: DSJ-2016-03
• Study Type: interventional
• Target: 400
• Locations: 9 countries
• Sites: 33

Brief 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.

Conditions

Primary Knee Arthroplasty

Keywords

complex primary, deformity, ligamentous laxity

Outcome Measures

Primary Outcomes (1)

• KOOS ADL

  Evaluate change from preoperative baseline to the 2 yr timepoint in patient reported functional outcome, KOOS-ADL for the ATTUNE® Revision TKA FB and RP configurations.

  2 Years

Secondary Outcomes (15)

• Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Living (KOOS-ADL)

  Baseline, 5 Year

• Patient's Knee Implant Performance (PKIP)

  Baseline, 5 Year

• American Knee Society Score

  Baseline, 5 Year

• EQ-5D-5L

  Baseline, 5 year

• VAS Pain Score

  Baseline, 5 year

Study Arms (1)

ATTUNE Revision knee system

OTHER

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

Device: ATTUNE Revision Knee System in Total Knee Arthroplasty

Interventions

ATTUNE Revision Knee System in Total Knee Arthroplasty DEVICE

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

Also known as: complex primary knee arthroplasty

ATTUNE Revision knee system

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive.
• The decision to have knee replacement with the study device is regardless of the research.
• The devices are to be used according to the approved indications.
• 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
• Subject is currently not bedridden.
• 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.
• 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.
• Subject has not been diagnosed with an inflammatory arthritis (including gout, rheumatoid, psoriatic etc.)

You may not qualify if:

• The Subject is a woman who is pregnant or lactating.
• 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.
• Subject had a contralateral amputation.
• Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement) or primary TKA in affected knee.
• Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.
• Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
• Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
• 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.
• 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.
• 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).
• Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator.
• Subject has been diagnosed with an inflammatory arthritis (including uncontrolled gout, rheumatoid, psoriatic etc.).

Sponsors & Collaborators

• DePuy Orthopaedics: lead

Study Sites (34)

Scripps Clinic Torrey Pines

San Diego, California, 92037, United States

Location

Colorado Joint Replacement

Denver, Colorado, 80210, United States

Location

Orthopaedic Center of the Rockies

Fort Collins, Colorado, 80525, United States

Location

Orthopedic Partners

Niantic, Connecticut, 06357, United States

Location

Florida Orthopedic Associates

DeLand, Florida, 32720, United States

Location

Arthroplasty Foundation

Louisville, Kentucky, 40215, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Rothman Institute

Egg Harbor, New Jersey, 08234, United States

Location

UNC Orthopaedics

Chapel Hill, North Carolina, 27514, United States

Location

OrthoCarolina Hip and Knee Center

Charlotte, North Carolina, 28207, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Southern Joint Replacement Institute

Nashville, Tennessee, 37203, United States

Location

Texas Institute for Hip & Knee Surgery

Austin, Texas, 78751, United States

Location

Fondren Orthopedic Group

Houston, Texas, 77030, United States

Location

Fremantle Hospital

Fremantle, Australia

Location

St. John of God Murdoch Hospital

Perth, Australia

Location

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

Linz, Austria

Location

London Health Sciences Centre University Hospital

London, Ontario, Canada

Location

Concordia Joint Replacement

Winnipeg, Canada

Location

CHRU La Cavale Blanche

Brest, France

Location

Centre Hospitalier Universitaire de Rennes

Rennes, France

Location

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

Munich, Germany

Location

Asklepios Orthopädische Klinik Lindenlohe

Schwandorf in Bayern, Germany

Location

South Infirmary Public Hospital

Cork, Ireland

Location

University Hospital Maastricht

Maastricht, Netherlands

Location

Wellington Hospital

Wellington, New Zealand

Location

Hampshire Hospitals NHS Foundation Trust

Basingstoke, United Kingdom

Location

Victoria Hospital NHS Fife

Kirkcaldy, United Kingdom

Location

Chapel Allerton Orthopaedic Centre

Leeds, United Kingdom

Location

James Cook University Hospital

Middlesbrough, United Kingdom

Location

The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, United Kingdom

Location

Nuffield Orthopaedic Centre

Oxford, United Kingdom

Location

Wrightington Hospital

Wigan, United Kingdom

Location

MeSH Terms

Conditions

Congenital Abnormalities; Joint Instability

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Grant Jamgochian

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: May 15, 2017
• Study Start: September 19, 2017
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (15); NZ (1); CA (2); FR (2); GB (7); IE (1); DE (2); AU (2); NL (1)