Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome Measures

Study Overview
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Brief Summary
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Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.

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

Conditions
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Journey II BCS Total Knee System

Intervention / Treatment
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* Device: Total knee arthroplasty with 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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No

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 BCS Total Knee System|Journey II BCS 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 | We are measuring the number of revision cases | Implantation through study completion, approximately 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health care utilization: Rehabilitation | Number of sessions and duration of rehabilitation in weeks | Implantation through study completion, approximately 8 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 8 years | 
| Knee Society Score (KSS) | Knee Society Score (KSS), a physician- and self-administered questionnaire consisting of several items to measure the outcomes; in this study, the following KOOS scores ranging from 0 to 100 were analyzed: Symptoms Score, Satisfaction Score, Expectation Score, Walking and Standing Score, Standard Activity Score, Advanced Activity Score, Discretionary Activity Score, and Functional Activities Score. Lower KSS scores indicated worse knee conditions. | Baseline through last study visit, approximately 8 years | 
| Visual Analogue Scale (VAS) | Visual Analogue Scale (VAS), a self-administered psychometric response instrument to evaluate subject-reported assessment of pain in each knee. There are multiple ways to present VAS scores; in this study, the numerical score ranged from 0 to 100 was used, with the higher score corresponding to the worse pain. | Baseline through last study visit, approximately 8 years | 
| Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index | The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, a self-administered questionnaire consisting of several items (grouped into symptoms, function, daily living, pain, etc) to measure the outcomes using the scores: Total WOMAC score (sum of all scores), WOMAC pain score (range 0 to 20), WOMAC stiffness score (range 0 to 8), and WOMAC physical function score (range of 0 to 68). The higher WOMAC scores corresponded to worse outcomes. | Baseline through last study visit, approximately 8 years | 
| Total Knee Assessment Score | Total Knee Assessment score is a self-administered questionnaire comprising multiple-choice questions regarding subjects' knee-related pain and limitations in ability to work, sports, and other daily living activities. In this study, the numbers and percentages of subjects answering each multiple-choice question were summarized. The higher percentage of subjects giving an answer indicating a higher level of limitations was indicative of worse outcomes. | Baseline through last study visit, approximately 8 years | 
| Oxford Knee Assessment (OKS) | Oxford Knee Assessment (OKS) is a self-administered questionnaire comprising multiple-choice questions aimed to grade subjects' ability to perform daily activities. The overall score is the sum of all items and range from 0 to 48, with a higher score corresponding to better outcomes. | Baseline through last study visit, approximately 8 years | 
| Knee Injury and Osteoarthritic Outcome Score (KOOS) | Knee Injury and Osteoarthritic Outcome Score (KOOS) is a self -administered joint-specific questionnaire comprising questions regarding subject's symptoms, knee stiffness, pain, function and daily living, function and sports and recreational activities, and quality of life; in this study, the following KOOS scores ranging from 0 to 100 (with a score of 0 indicating the worst possible symptoms) were analyzed: Pain Score, Other Symptoms Score, Function in Daily Living Score, Function in Sport and Recreation Score, and Quality of Life Score. | Baseline through last study visit, approximately 8 years | 
| Knee Injury and Osteoarthritic Outcome Score Jr (KOOS Jr) | Knee Injury and Osteoarthritic Outcome Score Jr (KOOS Jr) is a shorter self-administered alternative to KOOS focusing on joint pain, stiffness, and daily living and allowing for faster completion by the subject. In this study, the KOOS Interval Score ranging from 0 to 100 was analyzed (with a score of 0 indicating the worst possible symptoms). | Baseline through last study visit, approximately 8 years | 
| SF-12 Version 1 | SF-12 Version 1 is a self-administered multipurpose (not aimed to specific disease group) short form survey with questions selected from the longer SF-36 Health Survey and comprising the following scores: Physical Health Composite Score (range 0 for the worst health to 100 for the best health) and Mental Health Composite Score (range 0 for the worst health to 100 for the best health) | Baseline through last study visit, approximately 8 years |