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

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

Detailed Description
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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.

Official Title
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Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Device: Journey II BCS Total Knee System


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Journey II BCS Total Knee System<br>Subjects having TKA with Journey II BCS Total Knee System | Device: Journey II BCS Total Knee System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision Rate of Total Knee System | Number of revisions | implantation through study completion, approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of adverse events reported per ISO 14155 guidelines | implantation through study completion, approximately 3 years | 
| Health care utilization: Hospitalization | Length of hospital stay for primary (index) surgery | implantation through study completion, approximately 3 years | 
| Health care utilization: Hospitalization | Hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery (number and length of stay) | implantation through study completion, approximately 3 years | 
| Health care utilization: Rehabilitation | number of sessions and duration of rehabilitation in weeks | implantation through study completion, approximately 3 years | 
| Health care utilization: Outpatient visits | Number and type of outpatient visits | implantation through study completion, approximately 3 years | 
| Health Care Utilization: Re-operations | number of re-operations and revisions | implantation through study completion, approximately 3 years | 
| Patient reported outcomes | EQ-5D-3L | implantation through study completion, approximately 3 years | 
| Clinical outcomes | Knee Society Score | implantation through study completion, approximately 3 years | 
| Return to Work | Changes in employment status will be recorded with the date on which the change occurred and the change status. | implantation through study completion, approximately 3 years | 
| Technical Difficulties Encountered During Device Implantation | Number of technical difficulties encountered with the device | implantation through study completion, approximately 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomy