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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03153475
Registration number
NCT03153475
Ethics application status
Date submitted
7/05/2017
Date registered
15/05/2017
Date last updated
22/05/2024
Titles & IDs
Public title
ATTUNE Revision System in the Revision Total Knee Arthroplasty Population
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Scientific title
Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Revision Total Knee Arthroplasty
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Secondary ID [1]
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DSJ-2016-02
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Revision Total Knee Arthroplasty
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - ATTUNE Revision Knee System in Revision Total Knee Arthroplasty
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
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Survivorship
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Assessment method [1]
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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.
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Timepoint [1]
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5 Years
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Secondary outcome [1]
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Patient's Knee Implant Performance (PKIP)
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Assessment method [1]
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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)
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Timepoint [1]
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Baseline, 2 and 5 yr timepoints
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Secondary outcome [2]
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Knee Injury and Osteoarthritis Outcome Score Short form (KOOS-PS)
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Assessment method [2]
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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
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Timepoint [2]
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Baseline, 2 year and 5 Year
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Secondary outcome [3]
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American Knee Society Score
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Assessment method [3]
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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
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Timepoint [3]
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Baseline, 2 year, 5 year
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Secondary outcome [4]
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EQ-5D-5L
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Assessment method [4]
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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
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Timepoint [4]
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Baseline, 2 year and 5 year
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Secondary outcome [5]
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VAS Pain Score
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Assessment method [5]
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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).
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Timepoint [5]
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Baseline, 2 year and 5 year
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Secondary outcome [6]
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Patient Satisfaction
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Assessment method [6]
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Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported satisfaction as measured using a Likert scale.
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Timepoint [6]
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Baseline, 2 year and 5 year
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Secondary outcome [7]
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Adverse Events
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Assessment method [7]
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Evaluate type and frequency of Adverse Events
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Timepoint [7]
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Intraoperative, 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs.
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Secondary outcome [8]
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Readmissions
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Assessment method [8]
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Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic).
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Timepoint [8]
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6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs
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Secondary outcome [9]
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Survivorship
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Assessment method [9]
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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.
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Timepoint [9]
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1, 2, 3 and 4 years
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Secondary outcome [10]
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Frequency of radiolucent line occurrence
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Assessment method [10]
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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.
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Timepoint [10]
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1, 2 and 5 years
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Secondary outcome [11]
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Anatomic Tibiofemoral Alignment
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Assessment method [11]
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Evaluate any changes in anatomic tibiofemoral alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
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Timepoint [11]
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1, 2 and 5 years
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Secondary outcome [12]
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femoral component alignment
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Assessment method [12]
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Evaluate any changes in femoral component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
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Timepoint [12]
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1, 2 and 5 years
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Secondary outcome [13]
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Tibial component alignment
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Assessment method [13]
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Evaluate any changes in tibial component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
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Timepoint [13]
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1, 2 and 5 years
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Secondary outcome [14]
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Restoration of joint line
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Assessment method [14]
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Radiographically evaluate the restoration of joint line using the first postoperative radiographs according to the methodology of Figgie.
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Timepoint [14]
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First post-operative radiograph (1 day)
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Eligibility
Key inclusion 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.
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Minimum age
22
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/05/2017
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
31/03/2029
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Actual
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Sample size
Target
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Accrual to date
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Final
400
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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The Gold Coast Centre for Bone and Joint Surgery - Gold Coast
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Recruitment hospital [2]
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St. John of God Murdoch Hospital - Perth
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Recruitment postcode(s) [1]
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- Gold Coast
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Recruitment postcode(s) [2]
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- Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Colorado
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United States of America
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State/province [3]
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Connecticut
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Country [4]
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United States of America
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State/province [4]
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Florida
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Country [5]
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United States of America
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State/province [5]
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Kentucky
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Country [6]
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United States of America
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State/province [6]
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Mississippi
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Country [7]
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United States of America
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State/province [7]
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Missouri
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Country [8]
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United States of America
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State/province [8]
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New Hampshire
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Country [9]
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United States of America
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State/province [9]
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New Jersey
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Country [10]
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United States of America
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State/province [10]
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North Carolina
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Country [11]
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United States of America
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State/province [11]
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Ohio
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Country [12]
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United States of America
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State/province [12]
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Tennessee
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Country [13]
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United States of America
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State/province [13]
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Texas
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Country [14]
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Austria
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State/province [14]
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Linz
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Country [15]
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Belgium
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State/province [15]
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Antwerp
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Country [16]
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Canada
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State/province [16]
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Ontario
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Country [17]
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Canada
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State/province [17]
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Winnipeg
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Country [18]
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France
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State/province [18]
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Brest
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Country [19]
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France
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State/province [19]
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Rennes
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Germany
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Munich
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Germany
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State/province [21]
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Schwandorf
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Ireland
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Cork
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Italy
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Bergamo
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Country [24]
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Netherlands
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State/province [24]
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Maastricht
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New Zealand
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State/province [25]
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Wellington
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Switzerland
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Basel
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United Kingdom
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State/province [27]
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Basingstoke
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Country [28]
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United Kingdom
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State/province [28]
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Kirkcaldy
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Country [29]
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United Kingdom
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State/province [29]
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Leeds
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United Kingdom
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State/province [30]
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North Yorkshire
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Country [31]
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United Kingdom
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Oswestry
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United Kingdom
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Oxford
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Country [33]
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United Kingdom
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State/province [33]
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Wigan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
DePuy Orthopaedics
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03153475
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sukhjeet Kaur
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Address
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Sponsor GmbH
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03153475
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