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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03153475




Registration number
NCT03153475
Ethics application status
Date submitted
7/05/2017
Date registered
15/05/2017
Date last updated
18/07/2019

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 - 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.
Timepoint [1] 0 0
5 Years
Secondary outcome [1] 0 0
Patient's Knee Implant Performance (PKIP) - 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)
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) - 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
Timepoint [2] 0 0
Baseline, 2 year and 5 Year
Secondary outcome [3] 0 0
American Knee Society Score - 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
Timepoint [3] 0 0
Baseline, 2 year, 5 year
Secondary outcome [4] 0 0
EQ-5D-5L - 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
Timepoint [4] 0 0
Baseline, 2 year and 5 year
Secondary outcome [5] 0 0
VAS Pain Score - 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).
Timepoint [5] 0 0
Baseline, 2 year and 5 year
Secondary outcome [6] 0 0
Patient Satisfaction - Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported satisfaction as measured using a Likert scale.
Timepoint [6] 0 0
Baseline, 2 year and 5 year
Secondary outcome [7] 0 0
Adverse Events - Evaluate type and frequency of 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 - Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic).
Timepoint [8] 0 0
6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs
Secondary outcome [9] 0 0
Survivorship - 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.
Timepoint [9] 0 0
1, 2, 3 and 4 years
Secondary outcome [10] 0 0
Frequency of radiolucent line occurrence - 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.
Timepoint [10] 0 0
1, 2 and 5 years
Secondary outcome [11] 0 0
Anatomic Tibiofemoral Alignment - Evaluate any changes in anatomic tibiofemoral alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
Timepoint [11] 0 0
1, 2 and 5 years
Secondary outcome [12] 0 0
femoral component alignment - Evaluate any changes in femoral component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
Timepoint [12] 0 0
1, 2 and 5 years
Secondary outcome [13] 0 0
Tibial component alignment - Evaluate any changes in tibial component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
Timepoint [13] 0 0
1, 2 and 5 years
Secondary outcome [14] 0 0
Restoration of joint line - Radiographically evaluate the restoration of joint line using the first postoperative radiographs according to the methodology of Figgie.
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
Gender
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
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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
North Yorkshire
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
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.
Trial website
https://clinicaltrials.gov/show/NCT03153475
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ahmad S. Ismail, MS, CCRP
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
Ahmad S. Ismail, MS, CCRP
Address 0 0
Country 0 0
Phone 0 0
(574) 372-7553
Fax 0 0
Email 0 0
AIsmail6@its.jnj.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03153475