Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcomes Measures

Smith & Nephew, Inc.5 sites in 3 countries600 target enrollmentJuly 19, 2018

Overview

Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.

Registry

clinicaltrials.gov

Start Date

July 19, 2018

End Date

August 8, 2019

Last Updated

5 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II BCS Total Knee System for approved indication;
•The TKA occurred at least 12 weeks prior to enrollment
•Subject records contain Patient Reported Outcome data obtained ≤3 months prior to as well as ≥6 months post-enrollment.

•Subject received the JOURNEY II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty

Revision of one or more study device components

Time Frame: Implantation through study completion, approximately 8 years

We are measuring the number of revision cases

Health care utilization: Rehabilitation(Implantation through study completion, approximately 8 years)
Knee Injury and Osteoarthritic Outcome Score (KOOS)(Baseline through last study visit, approximately 8 years)
Knee Injury and Osteoarthritic Outcome Score Jr (KOOS Jr)(Baseline through last study visit, approximately 8 years)
Knee Society Score (KSS)(Baseline through last study visit, approximately 8 years)
Return to Work(Implantation through study completion, approximately 8 years)
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index(Baseline through last study visit, approximately 8 years)
Oxford Knee Assessment (OKS)(Baseline through last study visit, approximately 8 years)
Visual Analogue Scale (VAS)(Baseline through last study visit, approximately 8 years)
SF-12 Version 1(Baseline through last study visit, approximately 8 years)
Total Knee Assessment Score(Baseline through last study visit, approximately 8 years)