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ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population

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ClinicalTrials.gov Identifier: NCT03153449
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : September 7, 2022
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics

Tracking Information
First Submitted Date  ICMJE May 7, 2017
First Posted Date  ICMJE May 15, 2017
Last Update Posted Date September 7, 2022
Actual Study Start Date  ICMJE September 19, 2017
Estimated Primary Completion Date March 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
KOOS ADL [ Time Frame: 2 Years ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2020)
  • Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Living (KOOS-ADL) [ Time Frame: Baseline, 5 Year ]
    Evaluate change from preoperative baseline to the 5 yr timepoint in functional outcomes as measured using KOOS patient reported outcomes measure (PROM).
  • Patient's Knee Implant Performance (PKIP) [ Time Frame: Baseline, 5 Year ]
    Evaluate change from preoperative baseline to 5 yr timepoint in functional outcomes, satisfaction and quality of life assessments, as measured using the PKIP patient reported outcome measure
  • American Knee Society Score [ Time Frame: Baseline, 5 Year ]
    valuate change from preoperative baseline to 5 yr timepoint in functional outcomes assessments, patient satisfaction and expectations and clinical evaluations as measured using the AKS measure
  • EQ-5D-5L [ Time Frame: Baseline, 5 year ]
    Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes and quality of life assessments, as measured using the EQ-5D-5L patient reported outcome measure
  • VAS Pain Score [ Time Frame: Baseline, 5 year ]
    Evaluate change from preoperative baseline to 5 yr timepoint in patient reported pain severity as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale).
  • American Knee Society Score [ Time Frame: Baseline, 5 year ]
    Evaluate change from preoperative baseline to the 5 yr timepoint in patient reported satisfaction from the AKS 2011 over time as measured using a Likert scale.
  • American Knee Society Score (surgeon evaluation) [ Time Frame: Baseline, 5 year ]
    Estimate the change from preoperative baseline to the 5 yr timepoint in clinical outcomes using the 2011 AKS (surgeon evaluation)
  • Adverse Events [ Time Frame: Intraoperative, 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr. ]
    Evaluate type and frequency of Adverse Events
  • Readmissions [ Time Frame: 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr. ]
    Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic).
  • Survivorship [ Time Frame: 1, 2, 3, 4 and 5 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, 4 and 5 years.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
  • Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Living (KOOS-ADL) [ Time Frame: Baseline, 5 Year ]
    Evaluate change from preoperative baseline to the 5 yr timepoint in functional outcomes as measured using KOOS patient reported outcomes measure (PROM).
  • Patient's Knee Implant Performance (PKIP) [ Time Frame: Baseline, 5 Year ]
    Evaluate change from preoperative baseline to 5 yr timepoint in functional outcomes, satisfaction and quality of life assessments, as measured using the PKIP patient reported outcome measure
  • American Knee Society Score [ Time Frame: Baseline, 5 Year ]
    valuate change from preoperative baseline to 5 yr timepoint in functional outcomes assessments, patient satisfaction and expectations and clinical evaluations as measured using the AKS measure
  • EQ-5D-5L [ Time Frame: Baseline, 5 year ]
    Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes and quality of life assessments, as measured using the EQ-5D-5L patient reported outcome measure
  • VAS Pain Score [ Time Frame: Baseline, 5 year ]
    Evaluate change from preoperative baseline to 5 yr timepoint in patient reported pain severity as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale).
  • American Knee Society Score [ Time Frame: Baseline, 5 year ]
    Evaluate change from preoperative baseline to the 5 yr timepoint in patient reported satisfaction from the AKS 2011 over time as measured using a Likert scale.
  • American Knee Society Score [ Time Frame: Baseline, 5 year ]
    Estimate the change from preoperative baseline to the 5 yr timepoint in clinical outcomes using the 2011 AKS (surgeon evaluation)
  • Adverse Events [ Time Frame: Intraoperative, 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr. ]
    Evaluate type and frequency of Adverse Events
  • Readmissions [ Time Frame: 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr. ]
    Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic).
  • Survivorship [ Time Frame: 1, 2, 3, 4 and 5 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, 4 and 5 years.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Official Title  ICMJE Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary Total Knee Arthroplasty
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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Knee Arthroplasty
Intervention  ICMJE Device: ATTUNE Revision Knee System in Total Knee Arthroplasty
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
Other Name: complex primary knee arthroplasty
Study Arms  ICMJE ATTUNE Revision knee system
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
Intervention: Device: ATTUNE Revision Knee System in Total Knee Arthroplasty
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2017)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2028
Estimated Primary Completion Date March 31, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive.
  2. The decision to have knee replacement with the study device is regardless of the research.
  3. The devices are to be used according to the approved indications.
  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. 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.
  7. 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.
  8. Subject has not been diagnosed with an inflammatory arthritis (including gout, rheumatoid, psoriatic etc.)

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 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.
  3. Subject had a contralateral amputation.
  4. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement) or primary TKA in affected knee.
  5. Subject is currently diagnosed with radicular pain from the spine that radiates into the 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 or worker's compensation claims.
  8. 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.
  9. 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.
  10. 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).
  11. Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator.
  12. Subject has been diagnosed with an inflammatory arthritis (including uncontrolled gout, rheumatoid, psoriatic etc.).

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas G. Baboolal, PhD +44 7880 081389 tbaboola@its.jnj.com
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   France,   Germany,   Ireland,   Italy,   Netherlands,   New Zealand,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03153449
Other Study ID Numbers  ICMJE DSJ-2016-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party DePuy Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE DePuy Orthopaedics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Thomas G. Baboolal, PhD Sponsor GmbH
PRS Account DePuy Orthopaedics
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP