PS150 Total Knee Arthroplasty Outcomes Registry | NCT02319291

Studies
PS150 Total Knee Arthroplasty Outcomes Registry

NCT02319291

Sponsor

DePuy Orthopaedics

Status

Completed

Last Update Posted

Feb 22, 2023Actual

Enrollment

175Actual

Phase

Not provided

Conditions

Osteoarthritis
Rheumatoid Arthritis

Interventions

P.F.C. Sigma PS150 RP Total Knee System

Countries

Australia
South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2015Actual

Primary Completion Date

Nov 3, 2021Actual

Completion Date

Nov 3, 2021Actual

First Submitted Date

Dec 15, 2014

First Submission Date that Met QC Criteria

Dec 17, 2014

First Posted Date

Dec 18, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2023

Last Update Posted Date

Feb 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

175Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants		P.F.C. Sigma PS150 RP Total Knee System	Device: P.F.C. Sigma PS150 RP Total Knee System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
P.F.C. Sigma PS150 RP Total Knee System	Device	Total Knee Arthroplasty - surgical procedure to replace knee with metal implant	Participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Implant Survivorship	Lack of revision with revision meaning no removal or replacement of any TKA component.	5 years

Secondary Outcomes

Measure	Description	Time Frame
Knee Society Score - Knee Score	Descriptive statistics, including change from baseline (post-op minus pre-op)	1, 3 & 5 years
Knee Society Score - Function	Descriptive statistics, including change from baseline (post-op minus pre-op)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Exclusion Criteria:

There are no exclusion criteria for this registry.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients may be considered for inclusion in the registry if they meet the inclusion criteria below.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Dekkers, MBBS	Greenslopes Private Hospital, Brisbane	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Greenslopes Private Hospital		Greenslopes			Australia
Northern Orthopaedics

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided