Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome Measures (JIIPROMS)

Smith & Nephew

Status: Completed

Conditions: Journey II BCS Total Knee System

Treatments: Device: Total knee arthroplasty with Journey II BCS Total Knee System

Study type: Observational

Funder types: Industry

Identifiers

NCT03903731

16-4049-08B

Details and patient eligibility

About

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

Enrollment: 600 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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