PS150 Total Knee Arthroplasty Outcomes Registry

Completed

• Conditions: Rheumatoid Arthritis; Osteoarthritis
• Interventions: Device: P.F.C. Sigma PS150 RP Total Knee System

• Registration Number: NCT02319291
• Lead Sponsor: DePuy Orthopaedics

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 available

Study Timeline

• Study First Submitted: 2014-12-15
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-18
• Study Start: 2015-02-01
• Primary Completion: 2021-11-03
• Study Completion: 2021-11-03
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	P.F.C. Sigma PS150 RP Total Knee System	P.F.C. Sigma PS150 RP Total Knee System

Primary Outcome Measures

Name	Time	Method
Implant Survivorship	5 years	Lack of revision with revision meaning no removal or replacement of any TKA component.

Secondary Outcome Measures

Name	Time	Method
Flexion	1, 3 & 5 years	Descriptive statistics, including change from baseline (post-op minus pre-op)
Knee Society Score - Function	1, 3 & 5 years	Descriptive statistics, including change from baseline (post-op minus pre-op)
Knee Society Score - Knee Score	1, 3 & 5 years	Descriptive statistics, including change from baseline (post-op minus pre-op)
Extension	1, 3 & 5 years	Descriptive statistics, including change from baseline (post-op minus pre-op)
Adverse Events	1, 3 & 5 years	Type and frequency of adverse events
Pain sub-question of the Knee Society Score	1, 3 & 5 years	Descriptive statistics, including change from baseline (post-op minus pre-op)
Radiographic Analysis	1, 3 & 5 years	Descriptive statistics

Trial Locations

Locations (4)

Greenslopes Private Hospital; 🇦🇺 Greenslopes, Australia

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

Northern Orthopaedics; 🇦🇺 Sydney, Australia

Jeju National University Hospital; 🇰🇷 Jeju, Korea, Republic of