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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02319291




Registration number
NCT02319291
Ethics application status
Date submitted
15/12/2014
Date registered
18/12/2014
Date last updated
21/04/2020

Titles & IDs
Public title
PS150 Total Knee Arthroplasty Outcomes Registry
Scientific title
Outcomes of Total Knee Arthroplasty (TKA) Using the Sigma PS150 Primary Total Knee System
Secondary ID [1] 0 0
13004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
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

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Implant Survivorship - Lack of revision with revision meaning no removal or replacement of any TKA component.
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Knee Society Score - Knee Score - Descriptive statistics, including change from baseline (post-op minus pre-op)
Timepoint [1] 0 0
1, 3 & 5 years
Secondary outcome [2] 0 0
Knee Society Score - Function - Descriptive statistics, including change from baseline (post-op minus pre-op)
Timepoint [2] 0 0
1, 3 & 5 years
Secondary outcome [3] 0 0
Pain sub-question of the Knee Society Score - Descriptive statistics, including change from baseline (post-op minus pre-op)
Timepoint [3] 0 0
1, 3 & 5 years
Secondary outcome [4] 0 0
Flexion - Descriptive statistics, including change from baseline (post-op minus pre-op)
Timepoint [4] 0 0
1, 3 & 5 years
Secondary outcome [5] 0 0
Extension - Descriptive statistics, including change from baseline (post-op minus pre-op)
Timepoint [5] 0 0
1, 3 & 5 years
Secondary outcome [6] 0 0
Radiographic Analysis - Descriptive statistics
Timepoint [6] 0 0
1, 3 & 5 years
Secondary outcome [7] 0 0
Adverse Events - Type and frequency of adverse events
Timepoint [7] 0 0
1, 3 & 5 years

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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- There are no exclusion criteria for this registry.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [2] 0 0
Northern Orthopaedics - Sydney
Recruitment postcode(s) [1] 0 0
- Greenslopes
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Incheon
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Jeju

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02319291
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Dekkers, MBBS
Address 0 0
Greenslopes Private Hospital, Brisbane
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
Other publications