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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/NCT01746524
Registration number
NCT01746524
Ethics application status
Date submitted
5/12/2012
Date registered
11/12/2012
Date last updated
11/04/2019
Titles & IDs
Public title
Prospective, Multiconfiguration Study to Assess Functional Performance of Primary Total Knee Arthroplasty System
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Scientific title
Prospective, Single Arm Multiconfiguration Investigation to Assess Functional Performance of Attune™ Primary Total Knee Arthroplasty System
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Secondary ID [1]
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10004
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Universal Trial Number (UTN)
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Trial acronym
10004
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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
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - ATTUNE Primary Total Knee Arthroplasty
CR FB - Subjects receiving Cruciate Retaining Fixed Bearing configuration of ATTUNE Primary Knee Implant
PS FB - Subjects receiving Posterior Stabilized Fixed Bearing configuration of ATTUNE Primary Knee Implant
CR RP - Subjects receiving Cruciate Retaining Rotating Platform configuration of ATTUNE Primary Knee Implant
PS RP - Subjects receiving Posterior Stabilized Rotating Platform configuration of ATTUNE Primary Knee Implant
Treatment: Devices: ATTUNE Primary Total Knee Arthroplasty
Patients will undergo a primary, cemented total knee replacement using one of the four configurations of the Attune knee (CR FB, PS FB, CR RP, 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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Knee Injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score change from baseline.
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Assessment method [1]
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The KOOS ADL will be measured before surgery and at a minimum 1 year after surgery. The KOOS is a patient self-administered questionnaire that consists of 42 questions. 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. The change from baseline is the minimum 1 year (approximately 304 to 668 days) measurement minus the baseline measurement.
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Timepoint [1]
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One year or later (approximately 304 days or later)
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Secondary outcome [1]
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Patient Reported Outcome: Oxford Knee Score (OKS)
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Assessment method [1]
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The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having 5 Likert- like 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 [1]
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Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [2]
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Patient Reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
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Assessment method [2]
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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 [2]
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Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [3]
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Patient Report Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
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Assessment method [3]
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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 [3]
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Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [4]
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Type and Frequency of Adverse Events (AEs) for all enrolled subjects
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Assessment method [4]
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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 [4]
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< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [5]
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Evaluate primary cemented fixation through zonal radiographic analysis post-operatively
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Assessment method [5]
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Radiographs will be reviewed by an independent radiographic reviewer (IRR). Data from the IRR radiographic evaluations will be used for determination of radiographic success criteria.
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Timepoint [5]
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minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [6]
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Incidence of post-operative anterior knee pain and symptomatic/asymptomatic crepitus
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Assessment method [6]
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The Anterior Knee Pain and Crepitus questionnaire will be used. It is a 2 part questionnaire that is patient-self administered. The crepitus questions include frequency of crepitus and whether or not crepitus is symptomatic. The anterior knee pain contains 2 questions that collect frequency of pain and location of pain.
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Timepoint [6]
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Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [7]
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Evaluate surgeon learning curve on clinical and functional outcomes
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Assessment method [7]
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Each surgeon will implant devices into the first 10 Subjects which will be considered as 'learning curve cases'; these learning curve cases will not be pooled with post-learning curve cases unless learning curve analyses indicate that there is not a significant learning curve with regard to clinical or functional Subject outcomes.
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Timepoint [7]
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< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [8]
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Evaluate the impact of ligament balancing surgical technique on functional performance
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Assessment method [8]
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Description of the Subject's surgical procedure including such items as surgical approach and ligament balancing will be evaluated.
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Timepoint [8]
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Operatively (Day 0 - Date of Surgery)
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Secondary outcome [9]
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Psychometric Properties of the Patient Knee Implant Performance (PKIP)questionnaire
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Assessment method [9]
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The Pre and 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 [9]
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Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [10]
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Evaluate the functional outcome of patella resurfacing and non-resurfacing
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Assessment method [10]
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An exploratory comparison of results between knees with patella resurfacing versus knees without resurfacing will be conducted. A comparison of KOOS, PKIP, OKS, Knee Society (AKS), anterior knee pain incidence, and crepitus will be conducted.
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Timepoint [10]
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< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [11]
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Evaluate changes in femoral component and tibial component alignment
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Assessment method [11]
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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 [11]
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< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Eligibility
Key inclusion criteria
- Subject is male or female and between the ages of 22 and 80 years, inclusive.
- Subject was diagnosed with NIDJD.
- Subject is a suitable candidate for cemented primary TKA using the devices described
in the Clinical Investigation Plan (CIP)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 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 CIP.
- The devices specified in this CIP were implanted.
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Minimum age
22
Years
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Maximum age
80
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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 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 erythematosus, etc.).
- Subject is not comfortable with speaking, reading, and understanding questions and
providing responses in an available translated language for the PROs in the CIP.
- Subject has a medical condition with less than 2 years of life expectancy.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
1/11/2012
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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
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Actual
5/03/2018
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Sample size
Target
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Accrual to date
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Final
1138
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Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
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Recruitment hospital [1]
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Sutherland Hospital - Caringbah
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Recruitment hospital [2]
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Hornsby Ku-ring-gai Hospital - Hornsby
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Recruitment hospital [3]
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Wakefield Orthopaedic Clinic - Adelaide
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Recruitment hospital [4]
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Freemantle Hospital - Crawley
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Recruitment postcode(s) [1]
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2229 - Caringbah
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Recruitment postcode(s) [2]
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2077 - Hornsby
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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6009 - Crawley
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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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California
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United States of America
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State/province [2]
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Colorado
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United States of America
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State/province [3]
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Kentucky
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United States of America
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State/province [4]
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Nevada
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Country [5]
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United States of America
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State/province [5]
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New Hampshire
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Country [6]
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United States of America
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State/province [6]
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Ohio
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Country [7]
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United States of America
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State/province [7]
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Virginia
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Country [8]
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United States of America
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State/province [8]
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Washington
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Country [9]
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New Zealand
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State/province [9]
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Auckland
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Country [10]
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United Kingdom
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State/province [10]
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Fife
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United Kingdom
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State/province [11]
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Surrey
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Country [12]
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United Kingdom
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State/province [12]
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Harlow
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Country [13]
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United Kingdom
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State/province [13]
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Llandough
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Country [14]
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United Kingdom
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State/province [14]
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Middlesborough
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Country [15]
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United Kingdom
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State/province [15]
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York
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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
This post-marketing investigation will evaluate the functional knee performance of Subjects
who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one
of four contemporary knee configurations will be pooled to establish a contemporary dataset.
The primary objective of this study is to evaluate the pre-operative (approximately -90 to -1
day before surgery) to minimum one year (approximately 304 to 668 days) postoperative
functional performance improvement for the Attune™ primary, cemented TKA system as measured
by the activities of daily living (ADL)subscore of the Knee Osteoarthritis Outcomes Score
(KOOS)questionnaire (KOOS-ADL sub-score). This will be carried out for all four implant
configurations: cruciate retaining fixed bearing (Attune™ CR FB), cruciate retaining rotating
platform (Attune™ CR RP), posterior stabilized fixed bearing (Attune™ PS FB), and posterior
stabilized rotating platform (Attune™ PS RP).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01746524
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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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Ahmad S, Ismail, MS, CCRP
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Address
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DePuy Orthopaedics
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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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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01746524
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