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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01754363
Registration number
NCT01754363
Ethics application status
Date submitted
18/12/2012
Date registered
21/12/2012
Date last updated
15/08/2024
Titles & IDs
Public title
Survivorship of Attune Primary Total Knee Prosthesis
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Scientific title
Short, Medium and Long Term Survivorship of Attune Primary Knee Prosthesis
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Secondary ID [1]
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10008
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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:
Noninflammatory Degenerative Joint Disease
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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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 - Attune Primary Total Knee Replacement
Experimental: Attune Primary Total Knee Replacement - Subjects will receive one of the following Attune total knee implants:
Cruciate retaining fixed bearing (CR FB) Cruciate retaining rotating platform (CR RP) Posterior stabilized fixed bearing (PS FB) Posterior stabilized rotating platform (PS RP)
Treatment: Devices: Attune Primary Total Knee Replacement
Patients will undergo a primary total knee replacement using one of the four configurations of the Attune knee (CR FB, CR RP, PS FB, 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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Survivorship of each configuration.
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Assessment method [1]
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Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).
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Timepoint [1]
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Minimum 15 years (5414 - 5658 days)
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Secondary outcome [1]
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Survivorship
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Assessment method [1]
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Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).
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Timepoint [1]
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Minimum 5 years (1764 - 3588 days)
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Secondary outcome [2]
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Survivorship
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Assessment method [2]
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Kaplan-Meier survival analysis will be used to calculate the survivorship of all 4 configurations (CR FB, CR RP, PS FB, PS RP).
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Timepoint [2]
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Minimum 10 years (3589 - 5413 days)
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Secondary outcome [3]
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Implant fixation: Radiographic assessment of bone-implant interface performance
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Assessment method [3]
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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 [3]
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Minimum 1 year (304 - 668 days)
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Secondary outcome [4]
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Implant fixation: Radiographic assessment of bone-implant interface performance
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Assessment method [4]
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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 [4]
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Minimum 2 years (669 - 1763 days)
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Secondary outcome [5]
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Implant fixation: Radiographic assessment of bone-implant interface performance
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Assessment method [5]
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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 [5]
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Minimum 5 years (1764 - 3588 days)
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Secondary outcome [6]
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Implant fixation: Radiographic assessment of bone-implant interface performance
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Assessment method [6]
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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 [6]
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Minimum 10 years (3589 - 5413 days)
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Secondary outcome [7]
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Implant fixation: Radiographic assessment of bone-implant interface performance
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Assessment method [7]
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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 [7]
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Minimum 15 years (5414 - 5658 days)
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Secondary outcome [8]
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Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
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Assessment method [8]
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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 [8]
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Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
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Secondary outcome [9]
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Patient-reported Outcome: Oxford Knee Score
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Assessment method [9]
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The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having a Likert-lie response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OKS measures pain and general activities of daily living.
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Timepoint [9]
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Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
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Secondary outcome [10]
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Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)
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Assessment method [10]
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The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and includes 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 [10]
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Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
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Secondary outcome [11]
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Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
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Assessment method [11]
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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 [11]
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Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
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Secondary outcome [12]
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Patient-reported Outcome: Knee Society Score
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Assessment method [12]
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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). Likert responses are used, typically with five response options.
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Timepoint [12]
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Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
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Secondary outcome [13]
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Evaluate the impact of surgeon learning curve on clinical and functional outcomes
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Assessment method [13]
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A surgeon learning curve will be investigated by comparing learning curve cases (the pooled cohort of each surgeon's first 10 study Subjects) with all investigational Subjects. All primary and secondary outcomes will be compared across the learning curve and post-learning curve Subject cohorts.
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Timepoint [13]
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<1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
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Secondary outcome [14]
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Evaluate changes in femoral component and tibial component alignment
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Assessment method [14]
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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 [14]
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Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
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Secondary outcome [15]
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Type and Frequency of Adverse Events (AEs) for all enrolled subjects
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Assessment method [15]
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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 [15]
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Pre-op (-90 to -1 days before surgery), <1 year (1 - 303 days), minimum 1 year (304 - 668 days), minimum 2 years (669 - 1763 days), minimum 5 years (1764 - 3588 days), minimum 10 years (3589 - 5413 days), minimum 15 years (5414 - 5658 days).
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Eligibility
Key inclusion criteria
* Subject is male or female and between the ages of 22 and 75 years at the time of surgery, inclusive.
* Subject was diagnosed with NIDJD.
* Subject is a suitable candidate for cemented primary total knee arthroplasty using the devices described in this protocol with either resurfaced or non-resurfaced patellae.
* Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy.
* Subject is currently not bedridden.
* Subject in the opinion of the Clinical Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedure and follow-up visits and co-operate with investigational procedures.
* Subject must be comfortable with speaking, reading and understanding questions and providing responses in an available translated language for the PROs in the protocol.
* The devices specified in this protocol were implanted.
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Minimum age
22
Years
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Maximum age
75
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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
* 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 (unilateral, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
* Subject is currently experiencing radicular pain from the spine.
* Subject has participated in an IDE/IND clinical investigation with an investigational product in the last three months.
* Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
* Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to complete patient reported questionnaires.
* Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication.
* Subject has significant neurological or musculoskeletal disorders 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 erythematosis, etc.).
* Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the protocol.
* Subject has a medical condition with less than 5 years of life expectancy.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
NA
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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
1/02/2013
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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
1/02/2030
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Actual
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Sample size
Target
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Accrual to date
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Final
1542
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Canberra Hospital-Trauma & Orthopaedic Research Unit - Adelaide
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Recruitment postcode(s) [1]
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ACT 2600 - Adelaide
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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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Arizona
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United States of America
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California
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United States of America
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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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Indiana
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United States of America
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Iowa
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United States of America
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Missouri
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Texas
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Austria
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State/province [11]
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Lower Austria
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Austria
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Upper Austria
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Belgium
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Antwerp
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Canada
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Ontario
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Germany
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Bavaria
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Germany
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Heidelberg
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Hong Kong
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Hong Kong
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Korea, Republic of
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Dongjak-gu
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Korea, Republic of
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Seoul
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Malaysia
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Kuala Lumpur
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New Zealand
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Auckland
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Singapore
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Singapore
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Switzerland
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Zurich
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United Kingdom
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Fife
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United Kingdom
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Scotland
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United Kingdom
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Harlow
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United Kingdom
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London
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United Kingdom
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State/province [28]
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York
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
DePuy International
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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
This post-marketing investigation will evaluate the long term (up to 15 years) survivorship of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint disease. Data from Subjects who receive one of four knee configurations will be pooled to establish a contemporary dataset.
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Trial website
https://clinicaltrials.gov/study/NCT01754363
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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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Allyson Morris
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Address
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DePuy Synthes
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Contact person for scientific queries
No information has been provided regarding IPD availability
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/NCT01754363
Download to PDF