Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Revision of one or more study device components |
We are measuring the number of revision cases |
Implantation through study completion, approximately 8 years |
|
| Secondary |
Health care utilization: Rehabilitation |
Number of sessions and duration of rehabilitation in weeks |
Implantation through study completion, approximately 8 years |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
