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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02839850
Registration number
NCT02839850
Ethics application status
Date submitted
19/07/2016
Date registered
21/07/2016
Date last updated
22/05/2024
Titles & IDs
Public title
14022 ATTUNE Cementless RP Clinical Performance Evaluation
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Scientific title
Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty
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Secondary ID [1]
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14022
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL)
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Assessment method [1]
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The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales: pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
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Timepoint [1]
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Minimum 2 years (670-1033 days after surgery)
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Secondary outcome [1]
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Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
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Assessment method [1]
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The Pre Surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option.
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Timepoint [1]
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Minimum 2 years (670-1033 days after surgery)
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Secondary outcome [2]
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Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)
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Assessment method [2]
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The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales: pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
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Timepoint [2]
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Minimum 2 years (670-1033 days after surgery)
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Secondary outcome [3]
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Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011
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Assessment method [3]
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The Knee Society Score is a self-administered questionnaire. The subject completes questions regarding: Symptoms (3 questions), Patient Satisfaction (5 questions), Patient Expectations (3 questions), Functional Activities (5 questions), Standard Activities (6 questions), Advanced Activities (5 questions), and Discretionary Knee Activities ( 4 questions). The surgeon completes questions regarding objective knee indicators. Likert responses are used, typically with five response options.
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Timepoint [3]
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Minimum 2 years (670-1033 days after surgery)
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Secondary outcome [4]
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Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
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Assessment method [4]
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EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
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Timepoint [4]
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Minimum 2 years (670-1033 days after surgery)
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Secondary outcome [5]
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Modified VAS Pain Score: Pain and Satisfaction
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Assessment method [5]
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VAS Pain Score is a standardized instrument for use as a measure of pain and satisfaction that is designed for completion by the subject. This modified version has scores that are discrete numbers rather than a continual scale
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Timepoint [5]
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Minimum 2 years (670-1033 days after surgery)
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Secondary outcome [6]
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Type and Frequency of Adverse Events (AEs) for all enrolled subjects
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Assessment method [6]
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All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor.
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Timepoint [6]
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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)
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Secondary outcome [7]
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Survivorship
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Assessment method [7]
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Kaplan-Meier survival analysis will be used to calculate the survivorship of all 2 configurations (CR RP, PS RP)
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Timepoint [7]
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Minimum 2 years (670-1033 days after surgery)
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Secondary outcome [8]
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Survivorship
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Assessment method [8]
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Kaplan-Meier survival analysis will be used to calculate the survivorship of all 2 configurations (CR RP, PS RP)
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Timepoint [8]
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Minimum 5 years (1764-2190 days after surgery)
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Secondary outcome [9]
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Implant fixation: Radiographic assessment of bone-implant interface performance
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Assessment method [9]
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Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
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Timepoint [9]
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6 weeks (1-90 days after surgery)
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Secondary outcome [10]
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Implant fixation: Radiographic assessment of bone-implant interface performance
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Assessment method [10]
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Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
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Timepoint [10]
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6 months (91-303 days after surgery)
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Secondary outcome [11]
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Implant fixation: Radiographic assessment of bone-implant interface performance
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Assessment method [11]
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Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
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Timepoint [11]
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Minimum 1 year (304-669 days after surgery).
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Secondary outcome [12]
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Implant fixation: Radiographic assessment of bone-implant interface performance
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Assessment method [12]
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Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change >3degrees in any plane.
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Timepoint [12]
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Minimum 2 years (670-1033 days after surgery)
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Secondary outcome [13]
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Evaluate changes in femoral component and tibial component alignment
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Assessment method [13]
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Radiographs will be reviewed by an independent radiographic reviewer (IRR) in order to minimize bias of radiographic outcomes. Data from the IRR radiographic evaluations will be used to evaluate femoral and tibial component alignment over time.
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Timepoint [13]
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Minimum 2 years (670-1033 days after surgery)
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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.
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Minimum age
22
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2027
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Actual
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Sample size
Target
540
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Colorado
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United States of America
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Florida
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United States of America
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New Hampshire
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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State/province [6]
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North Carolina
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Country [7]
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United States of America
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Tennessee
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United States of America
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Texas
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Country [9]
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United States of America
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State/province [9]
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Virginia
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Country [10]
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Austria
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State/province [10]
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Upper Austria
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Country [11]
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Canada
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State/province [11]
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Alberta
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France
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State/province [12]
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Cedex
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France
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State/province [13]
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Salouel
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Germany
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State/province [14]
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Garmisch-Partenkirchen
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Ireland
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State/province [15]
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Cork
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Netherlands
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State/province [16]
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Noord-Brabant
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New Zealand
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State/province [17]
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Christchurch
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United Kingdom
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State/province [18]
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Lancashire
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United Kingdom
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State/province [19]
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Nottingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
DePuy Orthopaedics
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of this study is to examine the change from pre-operative baseline to
two year postoperative functional performance improvement for the ATTUNE primary, cementless
TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be
carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless
CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02839850
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sukhjeet Kaur
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Address
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Sponsor GmbH
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02839850
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