JIIPROMS: Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome Measures
Study Details
Study Description
Brief Summary
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Revision of one or more study device components [Implantation through study completion, approximately 8 years]
We are measuring the number of revision cases
Secondary Outcome Measures
- Health care utilization: Rehabilitation [Implantation through study completion, approximately 8 years]
Number of sessions and duration of rehabilitation in weeks
- 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.
- 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.
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II BCS Total Knee System for approved indication;
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The TKA occurred at least 12 weeks prior to enrollment
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Orthopaedics, University of Colorado Denver | Aurora | Colorado | United States | 80045 |
| 2 | Hospital for Special Surgery | New York | New York | United States | 10021 |
| 3 | Tennessee Orthopaedic Clinics | Knoxville | Tennessee | United States | 37922 |
| 4 | UZ Leuven | Leuven | Belgium | 3000 | |
| 5 | Anglesea Clinic Orthopaedics | Hamilton | New Zealand | 3204 |
Sponsors and Collaborators
- Smith & Nephew, Inc.
Investigators
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16-4049-08B