Overview

This trial is active, not recruiting.

Conditions osteoarthritis, rheumatoid arthritis
Treatment p.f.c. sigma ps150 rp total knee system
Sponsor DePuy Orthopaedics
Start date February 2015
End date July 2021
Trial size 175 participants
Trial identifier NCT02319291, 13004

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Arm
P.F.C. Sigma PS150 RP Total Knee System
p.f.c. sigma ps150 rp total knee system
Total Knee Arthroplasty - surgical procedure to replace knee with metal implant

Primary Outcomes

Measure
Implant Survivorship
time frame: 5 years

Secondary Outcomes

Measure
Knee Society Score - Knee Score
time frame: 1, 3 & 5 years
Knee Society Score - Function
time frame: 1, 3 & 5 years
Pain sub-question of the Knee Society Score
time frame: 1, 3 & 5 years
Flexion
time frame: 1, 3 & 5 years
Extension
time frame: 1, 3 & 5 years
Radiographic Analysis
time frame: 1, 3 & 5 years
Adverse Events
time frame: 1, 3 & 5 years

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Outcomes of Total Knee Arthroplasty (TKA) Using the Sigma PS150 Primary Total Knee System
Principal investigator Mark Dekkers, MBBS
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by DePuy Orthopaedics.