PS150 Total Knee Arthroplasty Outcomes Registry

Rheumatoid Arthritis Clinical Trial

Official title:

Outcomes of Total Knee Arthroplasty (TKA) Using the Sigma PS150 Primary Total Knee System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319291
• Other study ID #: 13004
• Status: Completed
• Start date: February 1, 2015
• Est. completion date: November 3, 2021

Study information

• Verified date: February 2023
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: November 3, 2021
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Device:
• P.F.C. Sigma PS150 RP Total Knee System
Total Knee Arthroplasty - surgical procedure to replace knee with metal implant

Locations

Country	Name	City	State
Australia	Greenslopes Private Hospital	Greenslopes
Australia	Northern Orthopaedics	Sydney
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Jeju National University Hospital	Jeju

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Countries where clinical trial is conducted

Australia,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Survivorship	Lack of revision with revision meaning no removal or replacement of any TKA component.	5 years
Secondary	Knee Society Score - Knee Score	Descriptive statistics, including change from baseline (post-op minus pre-op)	1, 3 & 5 years
Secondary	Knee Society Score - Function	Descriptive statistics, including change from baseline (post-op minus pre-op)	1, 3 & 5 years
Secondary	Pain sub-question of the Knee Society Score	Descriptive statistics, including change from baseline (post-op minus pre-op)	1, 3 & 5 years
Secondary	Flexion	Descriptive statistics, including change from baseline (post-op minus pre-op)	1, 3 & 5 years
Secondary	Extension	Descriptive statistics, including change from baseline (post-op minus pre-op)	1, 3 & 5 years
Secondary	Radiographic Analysis	Descriptive statistics	1, 3 & 5 years
Secondary	Adverse Events	Type and frequency of adverse events	1, 3 & 5 years