Status:
COMPLETED
Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
Brief Summary
The objective of this study is to estimate the safety and performance of Journey II BCS TKS.
Detailed 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 clin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 30 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 24 2018
Estimated Enrollment :
1694 Patients enrolled
Trial Details
Trial ID
NCT03292003
Start Date
December 30 2016
End Date
September 24 2018
Last Update
March 28 2019
Active Locations (12)
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1
University of Colorado Orthopaedics
Aurora, Colorado, United States, 80045
2
Andrews Research and Education Foundation
Gulf Breeze, Florida, United States, 32571
3
Methodist Sports Medicine
Indianapolis, Indiana, United States, 46280
4
Hospital for Special Surgery
New York, New York, United States