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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Knee Society Score - Knee Score
Timepoint [1] 0 0
1, 3 & 5 years
Secondary outcome [2] 0 0
Knee Society Score - Function
Timepoint [2] 0 0
1, 3 & 5 years
Secondary outcome [3] 0 0
Pain sub-question of the Knee Society Score
Timepoint [3] 0 0
1, 3 & 5 years
Secondary outcome [4] 0 0
Flexion
Timepoint [4] 0 0
1, 3 & 5 years
Secondary outcome [5] 0 0
Extension
Timepoint [5] 0 0
1, 3 & 5 years
Secondary outcome [6] 0 0
Radiographic Analysis
Timepoint [6] 0 0
1, 3 & 5 years
Secondary outcome [7] 0 0
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/11/2021
Sample size
Target
Accrual to date
Final
175
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
Trial website
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

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/NCT02319291