Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome Measures
- Conditions
- Journey II BCS Total Knee System
- Registration Number
- NCT03903731
- Lead Sponsor
- Smith & Nephew, Inc.
- Brief Summary
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method Health care utilization: Rehabilitation Implantation through study completion, approximately 8 years Number of sessions and duration of rehabilitation in weeks
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).
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.
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.
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.
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.
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.
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.
Trial Locations
- Locations (5)
Department of Orthopaedics, University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Tennessee Orthopaedic Clinics
🇺🇸Knoxville, Tennessee, United States
UZ Leuven
🇧🇪Leuven, Belgium
Anglesea Clinic Orthopaedics
🇳🇿Hamilton, New Zealand
Department of Orthopaedics, University of Colorado Denver🇺🇸Aurora, Colorado, United States