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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03153449




Registration number
NCT03153449
Ethics application status
Date submitted
7/05/2017
Date registered
15/05/2017

Titles & IDs
Public title
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Scientific title
Multi-Center Clinical Evaluation of the ATTUNE Revision System in Complex Primary Total Knee Arthroplasty
Secondary ID [1] 0 0
DSJ-2016-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary 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 Total Knee Arthroplasty

Other: 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


Treatment: Devices: 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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
KOOS ADL
Timepoint [1] 0 0
2 Years
Secondary outcome [1] 0 0
Knee Injury and Osteoarthritis Outcome Score - Activities of Daily Living (KOOS-ADL)
Timepoint [1] 0 0
Baseline, 5 Year
Secondary outcome [2] 0 0
Patient's Knee Implant Performance (PKIP)
Timepoint [2] 0 0
Baseline, 5 Year
Secondary outcome [3] 0 0
American Knee Society Score
Timepoint [3] 0 0
Baseline, 5 Year
Secondary outcome [4] 0 0
EQ-5D-5L
Timepoint [4] 0 0
Baseline, 5 year
Secondary outcome [5] 0 0
VAS Pain Score
Timepoint [5] 0 0
Baseline, 5 year
Secondary outcome [6] 0 0
American Knee Society Score
Timepoint [6] 0 0
Baseline, 5 year
Secondary outcome [7] 0 0
American Knee Society Score (surgeon evaluation)
Timepoint [7] 0 0
Baseline, 5 year
Secondary outcome [8] 0 0
Adverse Events
Timepoint [8] 0 0
Intraoperative, 6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr.
Secondary outcome [9] 0 0
Readmissions
Timepoint [9] 0 0
6 weeks, 1 yr., 2 yr., 3 yr., 4 yr., 5 yr.
Secondary outcome [10] 0 0
Survivorship
Timepoint [10] 0 0
1, 2, 3, 4 and 5 years
Secondary outcome [11] 0 0
Frequency of radiolucent line occurrence
Timepoint [11] 0 0
1, 2 and 5 years
Secondary outcome [12] 0 0
Anatomic Tibiofemoral Alignment
Timepoint [12] 0 0
1, 2 and 5 years
Secondary outcome [13] 0 0
Femoral component alignment
Timepoint [13] 0 0
1, 2 and 5 years
Secondary outcome [14] 0 0
Tibial component alignment
Timepoint [14] 0 0
1, 2 and 5 years
Secondary outcome [15] 0 0
Restoration of joint line
Timepoint [15] 0 0
First post-operative radiograph (1 day)

Eligibility
Key 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.)
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. 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.).

-

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2028
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Finders Private Hospital - Adelaide
Recruitment hospital [2] 0 0
St. John of God Murdoch Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Adelaide
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
Rennes
Country [19] 0 0
Germany
State/province [19] 0 0
Munich
Country [20] 0 0
Germany
State/province [20] 0 0
Schwandorf
Country [21] 0 0
Ireland
State/province [21] 0 0
Cork
Country [22] 0 0
Italy
State/province [22] 0 0
Verona
Country [23] 0 0
Netherlands
State/province [23] 0 0
Maastricht
Country [24] 0 0
New Zealand
State/province [24] 0 0
Wellington
Country [25] 0 0
Switzerland
State/province [25] 0 0
Basel
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Basingstoke
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Kirkcaldy
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Leeds
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Middlesbrough
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Oswestry
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Oxford
Country [32] 0 0
United Kingdom
State/province [32] 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
Grant Jamgochian
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
Grant Jamgochian
Address 0 0
Country 0 0
Phone 0 0
+1 484-685-6404
Fax 0 0
Email 0 0
[email protected]
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/NCT03153449