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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02839850




Registration number
NCT02839850
Ethics application status
Date submitted
19/07/2016
Date registered
21/07/2016

Titles & IDs
Public title
14022 ATTUNE Cementless RP Clinical Performance Evaluation
Scientific title
Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty
Secondary ID [1] 0 0
14022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Cementless Total Knee Arthroplasty

Experimental: ATTUNE Cementless RP TKA - Subjects will receive a cementless, rotating platform total knee arthroplasty


Treatment: Devices: Cementless Total Knee Arthroplasty
Patients will undergo a primary total knee replacement using one of the two configurations of the ATTUNE Cementless knee (CR RP or PS RP)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL)
Timepoint [1] 0 0
Minimum 2 years (670-1033 days after surgery)
Secondary outcome [1] 0 0
Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
Timepoint [1] 0 0
Minimum 2 years (670-1033 days after surgery)
Secondary outcome [2] 0 0
Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [2] 0 0
Minimum 2 years (670-1033 days after surgery)
Secondary outcome [3] 0 0
Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011
Timepoint [3] 0 0
Minimum 2 years (670-1033 days after surgery)
Secondary outcome [4] 0 0
Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
Timepoint [4] 0 0
Minimum 2 years (670-1033 days after surgery)
Secondary outcome [5] 0 0
Modified VAS Pain Score: Pain and Satisfaction
Timepoint [5] 0 0
Minimum 2 years (670-1033 days after surgery)
Secondary outcome [6] 0 0
Type and Frequency of Adverse Events (AEs) for all enrolled subjects
Timepoint [6] 0 0
Pre-op (-90 to -1 days before surgery), 6 weeks (1-90 days after surgery), 6 months (91-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-1033 days after surgery), minimum 5 years (1764-2190 days after surgery)
Secondary outcome [7] 0 0
Survivorship
Timepoint [7] 0 0
Minimum 2 years (670-1033 days after surgery)
Secondary outcome [8] 0 0
Survivorship
Timepoint [8] 0 0
Minimum 5 years (1764-2190 days after surgery)
Secondary outcome [9] 0 0
Implant fixation: Radiographic assessment of bone-implant interface performance
Timepoint [9] 0 0
6 weeks (1-90 days after surgery)
Secondary outcome [10] 0 0
Implant fixation: Radiographic assessment of bone-implant interface performance
Timepoint [10] 0 0
6 months (91-303 days after surgery)
Secondary outcome [11] 0 0
Implant fixation: Radiographic assessment of bone-implant interface performance
Timepoint [11] 0 0
Minimum 1 year (304-669 days after surgery).
Secondary outcome [12] 0 0
Implant fixation: Radiographic assessment of bone-implant interface performance
Timepoint [12] 0 0
Minimum 2 years (670-1033 days after surgery)
Secondary outcome [13] 0 0
Evaluate changes in femoral component and tibial component alignment
Timepoint [13] 0 0
Minimum 2 years (670-1033 days after surgery)

Eligibility
Key inclusion criteria
* Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive.
* Subject was diagnosed with NIDJD.
* Subject, in the opinion of the Investigator, is a suitable candidate for cementless primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
* 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
* Subject is currently not bedridden
* 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.
* Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROs 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
* The Subject is a woman who is pregnant or lactating.
* Contralateral knee has already been enrolled in this study .
* Subject had a contralateral amputation.
* Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
* Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.
* Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
* Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
* 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 their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
* 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.
* Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
* Subject is suffering from inflammatory arthritis (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
* Subject has a medical condition with less than five (5) years life expectancy.
* 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
1/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
540
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
New Hampshire
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Austria
State/province [10] 0 0
Upper Austria
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
France
State/province [12] 0 0
Cedex
Country [13] 0 0
France
State/province [13] 0 0
Salouel
Country [14] 0 0
Germany
State/province [14] 0 0
Garmisch-Partenkirchen
Country [15] 0 0
Ireland
State/province [15] 0 0
Cork
Country [16] 0 0
Netherlands
State/province [16] 0 0
Noord-Brabant
Country [17] 0 0
New Zealand
State/province [17] 0 0
Christchurch
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Lancashire
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Nottingham

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/NCT02839850