Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS): A Retrospective, Multicenter Study

Smith & Nephew, Inc.6 sites in 1 country586 target enrollmentMarch 27, 2019

Overview

Phase: N/A
Intervention: Not specified
Conditions: Journey II CR Total Knee System
Sponsor: Smith & Nephew, Inc.
Enrollment: 586
Locations: 6
Primary Endpoint: Number of adverse events reported per ISO 14155 guidelines
Status: Completed
Last Updated: 2 years ago

The objective of this study is to examine the safety and performance of the Journey II CR TKS based on retrospective data.

Registry

clinicaltrials.gov

Start Date

March 27, 2019

End Date

June 30, 2020

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•Subject received primary uni- or bilateral TKA with the Journey II CR TKS for an approved indication;
•The TKA occurred at least 12 weeks prior to enrollment

Number of adverse events reported per ISO 14155 guidelines

Time Frame: 7 years

Length of hospital stay for primary (index) surgery(7 years)
Number and type of outpatient visits(7 years)
Number of days before return to work(7 years)
Number of rehabilitation sessions(7 years)
Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery(7 years)
Duration of rehabilitation sessions in weeks(7 years)
Number of re-operations(7 years)
Quality of Life as measured by EQ-5D-3L score(7 years)
Patient Pain Level as measured by Knee Society Score (KSS)(7 years)
Number of technical difficulties encountered with the device(7 years)
Length of stay of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery(upon occurence through 7 years of study duration)