ATTUNE Revision System in the Revision Total Knee Arthroplasty Population

Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Revision Total Knee Arthroplasty

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 revision total knee arthroplasty.

Study Overview

• Status: Active, not recruiting
• Conditions: Revision Total Knee Arthroplasty
• Intervention / Treatment: Device: ATTUNE Revision Knee System in Revision Total Knee Arthroplasty

Detailed Description

The study is designed as a non-comparative, worldwide, multi-center study with up to 30 sites that will intend to implant a total of 400 Subjects (200 PS RP and 200 PS FB) with the study devices. The follow-up period of 5 years was selected to cover both the early post-operative period as well as the medium term period which is a good indicator of longer term survivorship.

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Gold Coast, Australia
    • The Gold Coast Centre for Bone and Joint Surgery
  • Perth, Australia
    • St. John of God Murdoch Hospital
• Austria
  • Linz, Austria
    • Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
• Belgium
  • Antwerp, Belgium
    • MoRe Foundation
• Canada
  • Winnipeg, Canada
    • Concordia Joint Replacement
  • Ontario
    • London, Ontario, Canada
      • London Health Sciences Centre University Hospital
• France
  • Brest, France
    • CHRU La Cavale Blanche
  • Rennes, France
    • Centre Hospitalier Universitaire de Rennes
• Germany
  • Munich, Germany
    • Klinik und Poliklinik für Orthopädie und Sportorthopädie am Klinikum rechts der Isar der Technischen Universität Münche
  • Schwandorf in Bayern, Germany
    • Asklepios Orthopädische Klinik Lindenlohe
• Ireland
  • Cork, Ireland
    • South Infirmary Public Hospital
• Italy
  • Bergamo, Italy
    • CLINICHE GAVAZZENI SPA aka Humanitas Castelli
• Netherlands
  • Maastricht, Netherlands
    • University Hospital Maastricht
• New Zealand
  • Wellington, New Zealand
    • Wellington Hospital
• Switzerland
  • Basel, Switzerland
    • Kantonsspital Baselland (Bruderholz, Liestal, Laufen), Department of Orthopaedic Surgery and Traumatology
• United Kingdom
  • Basingstoke, United Kingdom
    • Hampshire Hospitals NHS Foundation Trust
  • Kirkcaldy, United Kingdom
    • Victoria Hospital NHS Fife
  • Leeds, United Kingdom
    • Chapel Allerton Orthopaedic Centre
  • North Yorks, United Kingdom
    • James Cook University Hospital
  • Oswestry, United Kingdom
    • The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
  • Oxford, United Kingdom
    • Nuffield Orthopaedic Centre
  • Wigan, United Kingdom
    • Wrightington Hospital
• United States
  • California
    • San Diego, California, United States, 92037
      • Scripps Clinic Torrey Pines
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Joint Replacement
    • Fort Collins, Colorado, United States, 80525
      • Orthopaedic Center of the Rockies
  • Connecticut
    • Niantic, Connecticut, United States, 06357
      • Orthopedic Partners
  • Florida
    • DeLand, Florida, United States, 32720
      • Florida Orthopedic Associates
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Arthroplasty Foundation
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Ozark, Missouri, United States, 65721
      • Mery Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Egg Harbor, New Jersey, United States, 08234
      • Rothman Institute
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC Orthopaedics
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Hip and Knee Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Southern Joint Replacement Institute
  • Texas
    • Austin, Texas, United States, 78751
      • Texas Institute for Hip & Knee Surgery
    • Houston, Texas, United States, 77030
      • Fondren Orthopedic Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

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

1. The Subject is a woman who is pregnant or lactating.
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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

Device: 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 Names: previous unsuccessful knee replacement, knee revision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship	To evaluate the 5 year survivorship using Kaplan-Meier survival analysis, with revision for any reason as the endpoint, for the ATTUNE® Revision TKA PS FB and PS RP configurations.	5 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of radiolucent line occurrence	Evaluate ATTUNE® Revision TKA fixation through zonal radiographic analysis of the bone-implant interface at 1, 2 and 5 years after surgery compared to the first postoperative radiographs.	1, 2 and 5 years
Anatomic Tibiofemoral Alignment	Evaluate any changes in anatomic tibiofemoral alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.	1, 2 and 5 years
Tibial component alignment	Evaluate any changes in tibial component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.	1, 2 and 5 years
Restoration of joint line	Radiographically evaluate the restoration of joint line using the first postoperative radiographs according to the methodology of Figgie.	First post-operative radiograph (1 day)
Patient's Knee Implant Performance (PKIP)	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes, satisfaction and quality of life assessments, as measured using the PKIP patient reported outcome measure (overalll and subscores)	Baseline, 2 and 5 yr timepoints
Knee Injury and Osteoarthritis Outcome Score Short form (KOOS-PS)	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, as measured using the KOOS-PS patient reported outcome measures	Baseline, 2 year and 5 Year
American Knee Society Score	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, patient satisfaction and expectations and clinical evaluations as measured using the AKS measure	Baseline, 2 year, 5 year
EQ-5D-5L	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, as measured using the EQ-5D-5L patient reported outcome measures	Baseline, 2 year and 5 year
VAS Pain Score	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported pain severity as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale).	Baseline, 2 year and 5 year
Patient Satisfaction	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported satisfaction as measured using a Likert scale.	Baseline, 2 year and 5 year
Adverse Events	Evaluate type and frequency of Adverse Events	Intraoperative, 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs.
Readmissions	Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic).	6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs
Survivorship	Evaluate survivorship of the ATTUNE® Revision TKA system for the PS FB and PS RP configurations and the combined PS FB and PS RP configurations using Kaplan-Meier survival analysis at 1, 2, 3, and 4 years.	1, 2, 3 and 4 years
femoral component alignment	Evaluate any changes in femoral component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.	1, 2 and 5 years

Collaborators and Investigators

• Sponsor: DePuy Orthopaedics
• Investigators: Study Director: Sukhjeet Kaur, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2017
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: May 7, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Revision knee surgery, implant replacement
• Other Study ID Numbers: DSJ-2016-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes