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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.
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)
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)
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)
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
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
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
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
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
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
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
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
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
Address
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
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

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