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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
Scientific title
Multi-Center Clinical Evaluation of the ATTUNE® Revision System in Revision Total Knee Arthroplasty
Secondary ID [1] 0 0
DSJ-2016-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Revision Total Knee Arthroplasty 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survivorship
Timepoint [1] 0 0
5 Years
Secondary outcome [1] 0 0
Patient's Knee Implant Performance (PKIP)
Timepoint [1] 0 0
Baseline, 2 and 5 yr timepoints
Secondary outcome [2] 0 0
Knee Injury and Osteoarthritis Outcome Score Short form (KOOS-PS)
Timepoint [2] 0 0
Baseline, 2 year and 5 Year
Secondary outcome [3] 0 0
American Knee Society Score
Timepoint [3] 0 0
Baseline, 2 year, 5 year
Secondary outcome [4] 0 0
EQ-5D-5L
Timepoint [4] 0 0
Baseline, 2 year and 5 year
Secondary outcome [5] 0 0
VAS Pain Score
Timepoint [5] 0 0
Baseline, 2 year and 5 year
Secondary outcome [6] 0 0
Patient Satisfaction
Timepoint [6] 0 0
Baseline, 2 year and 5 year
Secondary outcome [7] 0 0
Adverse Events
Timepoint [7] 0 0
Intraoperative, 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs.
Secondary outcome [8] 0 0
Readmissions
Timepoint [8] 0 0
6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs
Secondary outcome [9] 0 0
Survivorship
Timepoint [9] 0 0
1, 2, 3 and 4 years
Secondary outcome [10] 0 0
Frequency of radiolucent line occurrence
Timepoint [10] 0 0
1, 2 and 5 years
Secondary outcome [11] 0 0
Anatomic Tibiofemoral Alignment
Timepoint [11] 0 0
1, 2 and 5 years
Secondary outcome [12] 0 0
femoral component alignment
Timepoint [12] 0 0
1, 2 and 5 years
Secondary outcome [13] 0 0
Tibial component alignment
Timepoint [13] 0 0
1, 2 and 5 years
Secondary outcome [14] 0 0
Restoration of joint line
Timepoint [14] 0 0
First post-operative radiograph (1 day)

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.
Minimum age
22 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2029
Actual
Sample size
Target
Accrual to date
Final
400
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Gold Coast Centre for Bone and Joint Surgery - Gold Coast
Recruitment hospital [2] 0 0
St. John of God Murdoch Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Gold Coast
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Mississippi
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Hampshire
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Austria
State/province [14] 0 0
Linz
Country [15] 0 0
Belgium
State/province [15] 0 0
Antwerp
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Winnipeg
Country [18] 0 0
France
State/province [18] 0 0
Brest
Country [19] 0 0
France
State/province [19] 0 0
Rennes
Country [20] 0 0
Germany
State/province [20] 0 0
Munich
Country [21] 0 0
Germany
State/province [21] 0 0
Schwandorf
Country [22] 0 0
Ireland
State/province [22] 0 0
Cork
Country [23] 0 0
Italy
State/province [23] 0 0
Bergamo
Country [24] 0 0
Netherlands
State/province [24] 0 0
Maastricht
Country [25] 0 0
New Zealand
State/province [25] 0 0
Wellington
Country [26] 0 0
Switzerland
State/province [26] 0 0
Basel
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Basingstoke
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Kirkcaldy
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Leeds
Country [30] 0 0
United Kingdom
State/province [30] 0 0
North Yorkshire
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Oswestry
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Oxford
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Wigan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
DePuy Orthopaedics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sukhjeet Kaur
Address 0 0
Sponsor GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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