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Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee arthroplasty with Journey II BCS Total Knee System | Device | Journey II BCS Total Knee System |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who received the Journey II BCS Total Knee System
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| Name | Affiliation | Role |
|---|---|---|
| Michael R. Dayton, MD | Department of Orthopaedics, University of Colorado Denver | Principal Investigator |
| David J. Mayman, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Harold E. Cates, MD | Tennessee Orthopaedic Clinics | Principal Investigator |
| Hilde Vandenneucker, MD | UZ Leuven | Principal Investigator |
| Peter Black, MBBCh | Anglesea Clinic Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopaedics, University of Colorado Denver | Aurora | Colorado | 80045 | United States | ||
| Hospital for Special Surgery |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| 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 |
| New York |
| New York |
| 10021 |
| United States |
| Tennessee Orthopaedic Clinics | Knoxville | Tennessee | 37922 | United States |
| UZ Leuven | Leuven | 3000 | Belgium |
| Anglesea Clinic Orthopaedics | Hamilton | 3204 | New Zealand |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |