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Trial record 1 of 1 for:    DSJ-2016-02
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ATTUNE Revision System in the Revision Total Knee Arthroplasty Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03153475
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics

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 revision total knee arthroplasty.

Condition or disease Intervention/treatment Phase
Revision Total Knee Arthroplasty Device: ATTUNE Revision Knee System in Revision Total Knee Arthroplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Revision Total Knee Arthroplasty
Actual Study Start Date : May 30, 2017
Estimated Primary Completion Date : February 24, 2025
Estimated Study Completion Date : February 24, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
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 Name: previous unsuccessful knee replacement, knee revision




Primary Outcome Measures :
  1. Survivorship [ Time Frame: 5 Years ]
    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.


Secondary Outcome Measures :
  1. Patient's Knee Implant Performance (PKIP) [ Time Frame: Baseline, 2 and 5 yr timepoints ]
    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)

  2. Knee Injury and Osteoarthritis Outcome Score Short form (KOOS-PS) [ Time Frame: Baseline, 2 year and 5 Year ]
    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

  3. American Knee Society Score [ Time Frame: Baseline, 2 year, 5 year ]
    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

  4. EQ-5D-5L [ Time Frame: Baseline, 2 year and 5 year ]
    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

  5. VAS Pain Score [ Time Frame: Baseline, 2 year and 5 year ]
    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).

  6. Patient Satisfaction [ Time Frame: Baseline, 2 year and 5 year ]
    Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported satisfaction as measured using a Likert scale.

  7. Adverse Events [ Time Frame: Intraoperative, 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs. ]
    Evaluate type and frequency of Adverse Events

  8. Readmissions [ Time Frame: 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs ]
    Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic).

  9. Survivorship [ Time Frame: 1, 2, 3 and 4 years ]
    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.

  10. Frequency of radiolucent line occurrence [ Time Frame: 1, 2 and 5 years ]
    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.

  11. Anatomic Tibiofemoral Alignment [ Time Frame: 1, 2 and 5 years ]
    Evaluate any changes in anatomic tibiofemoral alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.

  12. femoral component alignment [ Time Frame: 1, 2 and 5 years ]
    Evaluate any changes in femoral component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.

  13. Tibial component alignment [ Time Frame: 1, 2 and 5 years ]
    Evaluate any changes in tibial component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.

  14. Restoration of joint line [ Time Frame: First post-operative radiograph (1 day) ]
    Radiographically evaluate the restoration of joint line using the first postoperative radiographs according to the methodology of Figgie.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153475


Contacts
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Contact: Ahmad S. Ismail, MS, CCRP (574) 372-7553 AIsmail6@its.jnj.com
Contact: Susan J. Kemp, PhD +44 113 3877804 ext 7804 skemp1@its.jnj.com

Locations
Show Show 37 study locations
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
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Study Director: Ahmad S. Ismail, MS, CCRP Sponsor GmbH

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Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT03153475    
Other Study ID Numbers: DSJ-2016-02
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by DePuy Orthopaedics:
Revision knee surgery, implant replacement