Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study

Smith & Nephew

Status: Completed

Conditions: Total Knee Arthroplasty

Treatments: Device: Journey II BCS Total Knee System

Study type: Observational

Funder types: Industry

Identifiers

NCT03292003

16-4049-08

Details and patient eligibility

About

The objective of this study is to estimate the safety and performance of Journey II BCS TKS.

Full description

The objective of this study is to estimate the safety and performance of Journey II BCS TKS. Specifically, the study will establish revision rate, treatment- and device-related complications, and clinical outcomes in a large sample of subjects who received the study device. Subjects are screened consecutively, beginning at the earliest date of implantation at each investigative site. Further, reasons for revision will be collected and analyzed. An analysis will be performed to identify characteristics (patient, surgeon and surgical) associated with an increased risk for revision. Finally, clinical, functional and quality of life outcomes will be analyzed to the extent data is available, given the retrospective study design.

Enrollment: 1,694 patients

Sex: All

Volunteers: Accepts 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

Trial design

1,694 participants in 1 patient group

Journey II BCS Total Knee System

Description:

Subjects having TKA with Journey II BCS Total Knee System

Treatment:

Device: Journey II BCS Total Knee System