Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03153475
Registration number
NCT03153475
Ethics application status
Date submitted
7/05/2017
Date registered
15/05/2017
Titles & IDs
Public title
ATTUNE Revision System in the Revision Total Knee Arthroplasty Population
Query!
Scientific title
Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Revision Total Knee Arthroplasty
Query!
Secondary ID [1]
0
0
DSJ-2016-02
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Revision Total Knee Arthroplasty
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Survivorship
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
5 Years
Query!
Secondary outcome [1]
0
0
Patient's Knee Implant Performance (PKIP)
Query!
Assessment method [1]
0
0
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)
Query!
Timepoint [1]
0
0
Baseline, 2 and 5 yr timepoints
Query!
Secondary outcome [2]
0
0
Knee Injury and Osteoarthritis Outcome Score Short form (KOOS-PS)
Query!
Assessment method [2]
0
0
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
Query!
Timepoint [2]
0
0
Baseline, 2 year and 5 Year
Query!
Secondary outcome [3]
0
0
American Knee Society Score
Query!
Assessment method [3]
0
0
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
Query!
Timepoint [3]
0
0
Baseline, 2 year, 5 year
Query!
Secondary outcome [4]
0
0
EQ-5D-5L
Query!
Assessment method [4]
0
0
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
Query!
Timepoint [4]
0
0
Baseline, 2 year and 5 year
Query!
Secondary outcome [5]
0
0
VAS Pain Score
Query!
Assessment method [5]
0
0
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).
Query!
Timepoint [5]
0
0
Baseline, 2 year and 5 year
Query!
Secondary outcome [6]
0
0
Patient Satisfaction
Query!
Assessment method [6]
0
0
Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported satisfaction as measured using a Likert scale.
Query!
Timepoint [6]
0
0
Baseline, 2 year and 5 year
Query!
Secondary outcome [7]
0
0
Adverse Events
Query!
Assessment method [7]
0
0
Evaluate type and frequency of Adverse Events
Query!
Timepoint [7]
0
0
Intraoperative, 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs.
Query!
Secondary outcome [8]
0
0
Readmissions
Query!
Assessment method [8]
0
0
Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic).
Query!
Timepoint [8]
0
0
6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs
Query!
Secondary outcome [9]
0
0
Survivorship
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
1, 2, 3 and 4 years
Query!
Secondary outcome [10]
0
0
Frequency of radiolucent line occurrence
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
1, 2 and 5 years
Query!
Secondary outcome [11]
0
0
Anatomic Tibiofemoral Alignment
Query!
Assessment method [11]
0
0
Evaluate any changes in anatomic tibiofemoral alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
Query!
Timepoint [11]
0
0
1, 2 and 5 years
Query!
Secondary outcome [12]
0
0
femoral component alignment
Query!
Assessment method [12]
0
0
Evaluate any changes in femoral component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
Query!
Timepoint [12]
0
0
1, 2 and 5 years
Query!
Secondary outcome [13]
0
0
Tibial component alignment
Query!
Assessment method [13]
0
0
Evaluate any changes in tibial component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
Query!
Timepoint [13]
0
0
1, 2 and 5 years
Query!
Secondary outcome [14]
0
0
Restoration of joint line
Query!
Assessment method [14]
0
0
Radiographically evaluate the restoration of joint line using the first postoperative radiographs according to the methodology of Figgie.
Query!
Timepoint [14]
0
0
First post-operative radiograph (1 day)
Query!
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.
Query!
Minimum age
22
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
30/05/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/03/2029
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
400
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
The Gold Coast Centre for Bone and Joint Surgery - Gold Coast
Query!
Recruitment hospital [2]
0
0
St. John of God Murdoch Hospital - Perth
Query!
Recruitment postcode(s) [1]
0
0
- Gold Coast
Query!
Recruitment postcode(s) [2]
0
0
- Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kentucky
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Mississippi
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Missouri
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New Hampshire
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New Jersey
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Tennessee
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
Austria
Query!
State/province [14]
0
0
Linz
Query!
Country [15]
0
0
Belgium
Query!
State/province [15]
0
0
Antwerp
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Ontario
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Winnipeg
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Brest
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Rennes
Query!
Country [20]
0
0
Germany
Query!
State/province [20]
0
0
Munich
Query!
Country [21]
0
0
Germany
Query!
State/province [21]
0
0
Schwandorf
Query!
Country [22]
0
0
Ireland
Query!
State/province [22]
0
0
Cork
Query!
Country [23]
0
0
Italy
Query!
State/province [23]
0
0
Bergamo
Query!
Country [24]
0
0
Netherlands
Query!
State/province [24]
0
0
Maastricht
Query!
Country [25]
0
0
New Zealand
Query!
State/province [25]
0
0
Wellington
Query!
Country [26]
0
0
Switzerland
Query!
State/province [26]
0
0
Basel
Query!
Country [27]
0
0
United Kingdom
Query!
State/province [27]
0
0
Basingstoke
Query!
Country [28]
0
0
United Kingdom
Query!
State/province [28]
0
0
Kirkcaldy
Query!
Country [29]
0
0
United Kingdom
Query!
State/province [29]
0
0
Leeds
Query!
Country [30]
0
0
United Kingdom
Query!
State/province [30]
0
0
North Yorkshire
Query!
Country [31]
0
0
United Kingdom
Query!
State/province [31]
0
0
Oswestry
Query!
Country [32]
0
0
United Kingdom
Query!
State/province [32]
0
0
Oxford
Query!
Country [33]
0
0
United Kingdom
Query!
State/province [33]
0
0
Wigan
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
DePuy Orthopaedics
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03153475
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Sukhjeet Kaur
Query!
Address
0
0
Sponsor GmbH
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03153475