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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/NCT01497730




Registration number
NCT01497730
Ethics application status
Date submitted
20/12/2011
Date registered
22/12/2011
Date last updated
22/04/2019

Titles & IDs
Public title
10003 PRO Current Products
Scientific title
Multi-center, Non-comparative Study of Primary Total Knee Arthroplasty (TKA) Functional Performance
Secondary ID [1] 0 0
10003
Universal Trial Number (UTN)
Trial acronym
10003
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 - Total Knee Replacement

CR FB - Subjects receiving a Cruciate Retaining Fixed Bearing implant configuration

PS FB - Subjects Receiving a Posterior Stabilized Fixed Bearing implant configuration

CR RP - Subjects receiving a Cruciate Retaining Rotating Platform implant configuration

PS RP - Subjects receiving a Posterior Stabilized Rotating Platform implant configuration


Treatment: Devices: Total Knee Replacement
Subjects will receive one of the following total knee implants:
PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices.
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
Timepoint [1] 0 0
up to one year
Secondary outcome [1] 0 0
Evaluate the psychometric properties of PKIP
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
Evaluate the longitudinal functional performance of primary TKA
Timepoint [2] 0 0
< 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
Evaluate Incidence of Anterior Knee Pain
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
Evaluate incidence of asymptomatic and symptomatic crepitus
Timepoint [4] 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 [5] 0 0
Evaluate patients functional performance for PS knees, CR knees, FB knees, and RP knees
Timepoint [5] 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 this CIP with either a resurfaced or non-resurfaced patellae.

- Subject's TKA device was one of the total knee prostheses described under
Interventions.

- Subject is currently not bedridden.

- Subject has given voluntary, written informed consent to participate in this clinical
investigation, is willing and able to perform all study procedures and follow-up
visits and has authorized the transfer of his/her information to DePuy.

- 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 English.

- 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
1/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/08/2018
Sample size
Target
Accrual to date
Final
842
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [2] 0 0
Wakefield Orthopedic Clinic - Adelaide
Recruitment hospital [3] 0 0
Freemantle Hospital - Crawley
Recruitment hospital [4] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2077 - Hornsby
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
6009 - Crawley
Recruitment postcode(s) [4] 0 0
6000 - Perth
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
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
New Hampshire
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
New Zealand
State/province [11] 0 0
Auckland
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Fife
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Surrey
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Harlow
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Llandough
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Middlesborough
Country [17] 0 0
United Kingdom
State/province [17] 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 from different manufacturers will be pooled to
establish a contemporary dataset.

The primary objective of this study is to evaluate the functional performance as measured by
the activities of daily living (ADL) sub-score of the Knee Osteoarthritis Outcomes Score
(KOOS) patient-reported outcome (PRO) questionnaire of primary TKA at minimum one year
post-operation. This will be carried out for all four implant configurations. The final
endpoint is a 2-year evaluation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01497730
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01497730