Safety and Performance of Journey II XR Total Knee System

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 XR TKS based on retrospective data.

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

Conditions
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Journey II XR Total Knee System

Intervention / Treatment
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* Device: Journey II XR TKA


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 XR TKS for approved indication; The TKA occurred at least 12 weeks prior to enrollment. Exclusion Criteria: - None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Journey II XR TKA|Journey II XR Total Knee System|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision of one or more study device components | Measure of the number of revision cases | 12 weeks follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | All collected and reported AEs | 12 weeks follow up | 
| 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 | 
| Quality of Life: EQ-5D-3L | EuroQol Five Dimensions Questionnaire | Implantation through study completion, approximately 3 years | 
| Quality of Life: KSS | 2011 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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Journey II XR Total Knee System