Survivorship of Attune Primary Total Knee Prosthesis

NCT01754363 | Active Not Recruiting FDA Device

• 1 other identifier: 10008
• Study Type: interventional
• Target: 1,542
• Locations: 11 countries
• Sites: 27

Brief Summary

This post-marketing investigation will evaluate the long term (up to 15 years) survivorship of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint disease. Data from Subjects who receive one of four knee configurations will be pooled to establish a contemporary dataset.

Conditions

Noninflammatory Degenerative Joint Disease

Keywords

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Survivorship of each configuration.

  Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).

  Minimum 15 years (5414 - 5658 days)

Secondary Outcomes (15)

• Survivorship

  Minimum 5 years (1764 - 3588 days)

• Survivorship

  Minimum 10 years (3589 - 5413 days)

• Implant fixation: Radiographic assessment of bone-implant interface performance

  Minimum 1 year (304 - 668 days)

• Implant fixation: Radiographic assessment of bone-implant interface performance

  Minimum 2 years (669 - 1763 days)

• Implant fixation: Radiographic assessment of bone-implant interface performance

  Minimum 5 years (1764 - 3588 days)

Study Arms (1)

Attune Primary Total Knee Replacement

EXPERIMENTAL

Subjects will receive one of the following Attune total knee implants: Cruciate retaining fixed bearing (CR FB) Cruciate retaining rotating platform (CR RP) Posterior stabilized fixed bearing (PS FB) Posterior stabilized rotating platform (PS RP)

Device: Attune Primary Total Knee Replacement

Interventions

Attune Primary Total Knee Replacement DEVICE

Patients will undergo a primary total knee replacement using one of the four configurations of the Attune knee (CR FB, CR RP, PS FB, PS RP).

Attune Primary Total Knee Replacement

Eligibility Criteria

• Age: 22 Years - 75 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 75 years at the time of surgery, inclusive.
• Subject was diagnosed with NIDJD.
• Subject is a suitable candidate for cemented primary total knee arthroplasty using the devices described in this protocol with either resurfaced or non-resurfaced patellae.
• Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy.
• Subject is currently not bedridden.
• Subject in the opinion of the Clinical Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedure and follow-up visits and co-operate with investigational procedures.
• Subject must be comfortable with speaking, reading and understanding questions and providing responses in an available translated language for the PROs in the protocol.
• The devices specified in this protocol were implanted.

You may not qualify if:

• Subject is a woman who is pregnant or lactating.
• Contralateral knee has already been enrolled in this study.
• Subject had a contralateral amputation.
• Previous partial knee replacement (unilateral, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
• Subject is currently experiencing radicular pain from the spine.
• Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months.
• Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
• Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires.
• Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication.
• Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
• Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis, etc.).
• Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the protocol.
• Subject has a medical condition with less than 5 years of life expectancy.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (28)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Orthopaedic Specialty Institute

Orange, California, 92868, United States

Location

Florida Research Associates, LLC

DeLand, Florida, 32720, United States

Location

Center for Hip and Knee Surgery

Mooresville, Indiana, 46158, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Orthopedic One

Columbus, Ohio, 43213, United States

Location

OrthoNeuro

New Albany, Ohio, 43054, United States

Location

Penn State Hershey Bone & Joint Institute

Hershey, Pennsylvania, 17033, United States

Location

Texas Institute for Hip and Knee Surgery, LLC

Austin, Texas, 78705, United States

Location

Canberra Hospital-Trauma & Orthopaedic Research Unit

Adelaide, South Australia, ACT 2600, Australia

Location

Univ.-Klinik für Orthopädie

Vienna, Lower Austria, 1090, Austria

Location

Krankenhaus der Barmherzigen

Linz, Upper Austria, 4010, Austria

Location

Monica Camputs O.L.V. Middelares

Antwerp, 2100, Belgium

Location

University of Western Ontario-Department of Orthopaedic Surgery

London, Ontario, N6A 5A5, Canada

Location

Orthopädische Klinik für die Universität Regensburg

Bad Abbach, Bavaria, 3077, Germany

Location

UniversitatsKlinikum Heidelberg

Heidelberg, 69118, Germany

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Ascot Hospital

Auckland, New Zealand

Location

Singapore General Hospital-Dept of Orthopaedic Surgery

Singapore, 169608, Singapore

Location

Seoul National University Boramae Hospital

Seoul, Dongjak-gu, 156-707, South Korea

Location

Seoul National University Hospital

Seoul, 110-714, South Korea

Location

Queen Mary Hospital

Dunfermline, Fife, KY12 OSU, United Kingdom

Location

Robert Jones & Agnes Hunt Orthopaedic Hospital

Gobowen, Oswestry, SY10 7AG, United Kingdom

Location

New Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

Princess Alexandria Hospital

Harlow, CM20 1QX, United Kingdom

Location

Clifton Park NHS Treatment Centre

York, YO30 5RA, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Allyson Morris

  DePuy Synthes

  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: December 18, 2012
• First Posted: December 21, 2012
• Study Start: February 1, 2013
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

KR (2); MY (1); SG (1); HK (1); AU (2); BE (1); NZ (1); US (10); GB (5); DE (2); CA (1)