Trial Review

Please note that the ANZCTR website will be unavailable from 1:00pm until 2:00pm (AEST) on Thursday 10th of April for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.


The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Prospective, Single Arm Multiconfiguration Investigation to Assess Functional Performance of Attune™ Primary Total Knee Arthroplasty System
Secondary ID [1] 0 0
10004
Universal Trial Number (UTN)
Trial acronym
10004
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
Observational
Patient registry
Target follow-up duration
Target follow-up type
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).
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Knee Injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score change from baseline.
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
One year or later (approximately 304 days or later)
Secondary outcome [1] 0 0
Patient Reported Outcome: Oxford Knee Score (OKS)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
Patient Reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
Patient Report Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
Assessment method [3] 0 0
EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
Type and Frequency of Adverse Events (AEs) for all enrolled subjects
Assessment method [4] 0 0
All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor.
Timepoint [4] 0 0
< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Secondary outcome [5] 0 0
Evaluate primary cemented fixation through zonal radiographic analysis post-operatively
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Secondary outcome [6] 0 0
Incidence of post-operative anterior knee pain and symptomatic/asymptomatic crepitus
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
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)
Secondary outcome [7] 0 0
Evaluate surgeon learning curve on clinical and functional outcomes
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Secondary outcome [8] 0 0
Evaluate the impact of ligament balancing surgical technique on functional performance
Assessment method [8] 0 0
Description of the Subject's surgical procedure including such items as surgical approach and ligament balancing will be evaluated.
Timepoint [8] 0 0
Operatively (Day 0 - Date of Surgery)
Secondary outcome [9] 0 0
Psychometric Properties of the Patient Knee Implant Performance (PKIP)questionnaire
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
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)
Secondary outcome [10] 0 0
Evaluate the functional outcome of patella resurfacing and non-resurfacing
Assessment method [10] 0 0
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.
Timepoint [10] 0 0
< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
Secondary outcome [11] 0 0
Evaluate changes in femoral component and tibial component alignment
Assessment method [11] 0 0
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.
Timepoint [11] 0 0
< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)

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.
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 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/03/2018
Sample size
Target
Accrual to date
Final
1138
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
Sutherland Hospital - Caringbah
Recruitment hospital [2] 0 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [3] 0 0
Wakefield Orthopaedic Clinic - Adelaide
Recruitment hospital [4] 0 0
Freemantle Hospital - Crawley
Recruitment postcode(s) [1] 0 0
2229 - Caringbah
Recruitment postcode(s) [2] 0 0
2077 - Hornsby
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
6009 - Crawley
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
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Nevada
Country [5] 0 0
United States of America
State/province [5] 0 0
New Hampshire
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Fife
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Surrey
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Harlow
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Llandough
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Middlesborough
Country [15] 0 0
United Kingdom
State/province [15] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
DePuy Orthopaedics
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ahmad S, Ismail, MS, CCRP
Address 0 0
DePuy Orthopaedics
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
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/NCT01746524