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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
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).
Trial website
https://clinicaltrials.gov/study/NCT01746524
Trial related presentations / publications
Hamilton WG, Brenkel IJ, Barnett SL, Allen PW, Dwyer KA, Lesko JP, Kantor SR, Clatworthy MG. Comparison of Existing and New Total Knee Arthroplasty Implant Systems From the Same Manufacturer: A Prospective, Multicenter Study. J Am Acad Orthop Surg Glob Res Rev. 2021 Dec 15;5(12):e21.00136. doi: 10.5435/JAAOSGlobal-D-21-00136.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01746524