Journey II BCS Total Knee System
Conditions
Brief summary
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.
Interventions
DEVICETotal knee arthroplasty with Journey II BCS Total Knee System
Journey II BCS Total Knee System
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revision of one or more study device components | Implantation through study completion, approximately 8 years | We are measuring the number of revision cases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Return to Work | Implantation through study completion, approximately 8 years | Changes in employment status will be recorded with the date on which the change occurred and the change status. |
| Knee Society Score (KSS) | Baseline through last study visit, approximately 8 years | 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. |
| Visual Analogue Scale (VAS) | Baseline through last study visit, approximately 8 years | 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. |
| Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index | Baseline through last study visit, approximately 8 years | 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. |
| Health care utilization: Rehabilitation | Implantation through study completion, approximately 8 years | Number of sessions and duration of rehabilitation in weeks |
| Oxford Knee Assessment (OKS) | Baseline through last study visit, approximately 8 years | 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. |
| Knee Injury and Osteoarthritic Outcome Score (KOOS) | Baseline through last study visit, approximately 8 years | 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. |
| Knee Injury and Osteoarthritic Outcome Score Jr (KOOS Jr) | Baseline through last study visit, approximately 8 years | 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). |
| SF-12 Version 1 | Baseline through last study visit, approximately 8 years | 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) |
| Total Knee Assessment Score | Baseline through last study visit, approximately 8 years | 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. |
Countries
Belgium, New Zealand, United States
Outcome results
None listed