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

N/ACompletedNCT03292003

Smith & Nephew, Inc.1,694 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

1,694

Conditions

Total Knee Arthroplasty

Interventions

Journey II BCS Total Knee SystemDEVICE

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (12)

University of Colorado Orthopaedics

Aurora, Colorado, United States

Andrews Research and Education Foundation

Gulf Breeze, Florida, United States

Methodist Sports Medicine

Indianapolis, Indiana, United States