Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS)

Study Overview
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Brief Summary
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The objective of this study is to examine the safety and performance of the Journey II CR TKS based on retrospective data.

Official Title
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Safety and Performance of JOURNEY™ II Cruciate Retaining (CR) Total Knee System (TKS): A Retrospective, Multicenter Study

Conditions
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Journey II CR Total Knee System

Intervention / Treatment
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* Device: Total knee arthroplasty with Journey II CR Total Knee System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject received primary uni- or bilateral TKA with the Journey II CR TKS for an approved indication; The TKA occurred at least 12 weeks prior to enrollment Exclusion Criteria: None
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Total knee arthroplasty with Journey II CR Total Knee System|TKA with Journey II CR Total Knee System|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events reported per ISO 14155 guidelines |  | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay for primary (index) surgery |  | 7 years | 
| Number of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery |  | 7 years | 
| Length of stay of hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery |  | upon occurence through 7 years of study duration | 
| Number of rehabilitation sessions |  | 7 years | 
| Duration of rehabilitation sessions in weeks |  | 7 years | 
| Number and type of outpatient visits |  | 7 years | 
| Number of re-operations |  | 7 years | 
| Quality of Life as measured by EQ-5D-3L score | The EQ-5D-3L will be collected at each follow up visit. It consists of two pages - the EQ-5D descriptive system (page one) and the EQ visual analogue scale (EQ VAS) (page two). The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular dimension. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents. | 7 years | 
| Patient Pain Level as measured by Knee Society Score (KSS) | Combines an objective physician-derived component with a subjective subject-derived component. The objective section rates alignment, instability, joint motion and symptoms. Patient reported expectations and satisfaction questions evaluate pain relief, functional abilities, satisfaction and fulfillment of expectations using a subjective perspective. A functional score is derived from assessments of walking and standing, standard activities, advanced activities and discretionary activities. | 7 years | 
| Number of days before return to work |  | 7 years | 
| Number of technical difficulties encountered with the device |  | 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Journey II CR Total Knee System