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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/NCT02319291
Registration number
NCT02319291
Ethics application status
Date submitted
15/12/2014
Date registered
18/12/2014
Date last updated
22/02/2023
Titles & IDs
Public title
PS150 Total Knee Arthroplasty Outcomes Registry
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Scientific title
Outcomes of Total Knee Arthroplasty (TKA) Using the Sigma PS150 Primary Total Knee System
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Secondary ID [1]
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13004
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Universal Trial Number (UTN)
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Trial acronym
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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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0
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Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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0
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Osteoarthritis
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Intervention/exposure
Study type
Observational [Patient Registry]
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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 - P.F.C. Sigma PS150 RP Total Knee System
Participants - P.F.C. Sigma PS150 RP Total Knee System
Treatment: Devices: P.F.C. Sigma PS150 RP Total Knee System
Total Knee Arthroplasty - surgical procedure to replace knee with metal implant
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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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Implant Survivorship
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Assessment method [1]
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Lack of revision with revision meaning no removal or replacement of any TKA component.
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Timepoint [1]
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5 years
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Secondary outcome [1]
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Knee Society Score - Knee Score
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Assessment method [1]
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Descriptive statistics, including change from baseline (post-op minus pre-op)
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Timepoint [1]
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1, 3 & 5 years
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Secondary outcome [2]
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Knee Society Score - Function
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Assessment method [2]
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Descriptive statistics, including change from baseline (post-op minus pre-op)
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Timepoint [2]
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1, 3 & 5 years
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Secondary outcome [3]
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Pain sub-question of the Knee Society Score
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Assessment method [3]
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Descriptive statistics, including change from baseline (post-op minus pre-op)
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Timepoint [3]
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1, 3 & 5 years
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Secondary outcome [4]
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Flexion
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Assessment method [4]
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Descriptive statistics, including change from baseline (post-op minus pre-op)
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Timepoint [4]
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1, 3 & 5 years
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Secondary outcome [5]
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Extension
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Assessment method [5]
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Descriptive statistics, including change from baseline (post-op minus pre-op)
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Timepoint [5]
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1, 3 & 5 years
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Secondary outcome [6]
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Radiographic Analysis
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Assessment method [6]
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Descriptive statistics
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Timepoint [6]
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1, 3 & 5 years
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Secondary outcome [7]
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Adverse Events
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Assessment method [7]
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Type and frequency of adverse events
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Timepoint [7]
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1, 3 & 5 years
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Eligibility
Key inclusion criteria
- Primary total knee replacement for any indication in accordance with the Instructions
For Use accompanying the SIGMA PS150 implant.
- Signed Informed Patient Consent
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Minimum age
No limit
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Maximum age
No limit
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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
- There are no exclusion criteria for this registry.
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Study design
Purpose
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Duration
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Selection
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Timing
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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
1/02/2015
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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
3/11/2021
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Sample size
Target
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Accrual to date
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Final
175
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Greenslopes Private Hospital - Greenslopes
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Recruitment hospital [2]
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Northern Orthopaedics - Sydney
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Recruitment postcode(s) [1]
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- Greenslopes
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Recruitment postcode(s) [2]
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- Sydney
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Recruitment outside Australia
Country [1]
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Korea, Republic of
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State/province [1]
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Incheon
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Country [2]
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Korea, Republic of
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State/province [2]
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Jeju
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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 registry is intended to evaluate the clinical outcomes of the DePuy P.F.C. Sigma PS150
RP Total Knee System. 200 participants will be enrolled prospectively or retrospectively and
the follow up period will be 5 years. Data collection will include Radiographic Analysis,
Knee Society Evaluation and Adverse Events.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02319291
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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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Mark Dekkers, MBBS
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Address
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Greenslopes Private Hospital, Brisbane
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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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/NCT02319291
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