Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study
- Conditions
- Total Knee Arthroplasty
- Interventions
- Device: Journey II BCS Total Knee System
- Registration Number
- NCT03292003
- Lead Sponsor
- Smith & Nephew, Inc.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1694
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Journey II BCS Total Knee System Journey II BCS Total Knee System Subjects having TKA with Journey II BCS Total Knee System
- Primary Outcome Measures
Name Time Method Revision Rate of Total Knee System implantation through study completion, approximately 3 years Number of revisions
- Secondary Outcome Measures
Name Time Method Adverse Events implantation through study completion, approximately 3 years Number of adverse events reported per ISO 14155 guidelines
Clinical outcomes implantation through study completion, approximately 3 years Knee Society Score
Patient reported outcomes implantation through study completion, approximately 3 years EQ-5D-3L
Health care utilization: Hospitalization implantation through study completion, approximately 3 years Hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery (number and length of stay)
Health care utilization: Rehabilitation implantation through study completion, approximately 3 years number of sessions and duration of rehabilitation in weeks
Return to Work implantation through study completion, approximately 3 years Changes in employment status will be recorded with the date on which the change occurred and the change status.
Technical Difficulties Encountered During Device Implantation implantation through study completion, approximately 3 years Number of technical difficulties encountered with the device
Health care utilization: Outpatient visits implantation through study completion, approximately 3 years Number and type of outpatient visits
Health Care Utilization: Re-operations implantation through study completion, approximately 3 years number of re-operations and revisions
Trial Locations
- Locations (12)
TN Orthopaedic Foundation for Education and Research
🇺🇸Knoxville, Tennessee, United States
UZ Leuven Campus
🇧🇪Pellenberg, Belgium
Providence Regional Medical Center
🇺🇸Everett, Washington, United States
Christen Ortho AG
🇨🇭Bern, Switzerland
Jesse Ziekenhuis
🇧🇪Hasselt, Belgium
Marra Knee and Shoulder Center
🇺🇸Wheeling, West Virginia, United States
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
Hospital for Special Surgery
🇺🇸New York, New York, United States
University Orthopaedics Center
🇺🇸State College, Pennsylvania, United States
San Antonio Orthopaedic Specialists
🇺🇸San Antonio, Texas, United States