Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Cartilage Strain at baseline |
Cartilage strain will be assessed using images from MRIs. |
Baseline |
|
Primary |
Cartilage Strain at baseline at six months post-surgery |
Cartilage strain will be assessed using images from MRIs. |
6 months post-surgery |
|
Primary |
Western Ontario Shoulder Instability Index (WOSI) at baseline |
The Western Ontario Shoulder Instability Index (WOSI) is an instability-specific patient reported outcome (PRO) measure for individuals with shoulder instability that was designed for use as a primary outcome measure in clinical trials evaluating treatments for patients with shoulder instability. The WOSI questionnaire consists of 21 items, each scored on a 100mm Visual Analogue Scale (VAS). Each item falls into one of the domains of physical function, sports/recreation/work, lifestyle and emotional well-being. Each question is scored between 0-100 points and the summation of all the questions results in a final WOSI score. The final score ranges from 0 (no decrease in shoulder-related quality of life) to 2100 (extreme distress in shoulder-related quality of life). |
Baseline |
|
Primary |
Western Ontario Shoulder Instability Index (WOSI) at six months post-surgery |
The Western Ontario Shoulder Instability Index (WOSI) is an instability-specific patient reported outcome (PRO) measure for individuals with shoulder instability that was designed for use as a primary outcome measure in clinical trials evaluating treatments for patients with shoulder instability. The WOSI questionnaire consists of 21 items, each scored on a 100mm Visual Analogue Scale (VAS). Each item falls into one of the domains of physical function, sports/recreation/work, lifestyle and emotional well-being. Each question is scored between 0-100 points and the summation of all the questions results in a final WOSI score. The final score ranges from 0 (no decrease in shoulder-related quality of life) to 2100 (extreme distress in shoulder-related quality of life). |
6 months post-surgery |
|
Primary |
American Shoulder and Elbow Surgeon (ASES) Score at baseline |
The final American Shoulder and Elbow Surgeon (ASES) Score is obtained by summing the pain and functional portions with higher scores indicating better outcomes. |
Baseline |
|
Primary |
American Shoulder and Elbow Surgeon (ASES) Score at six months post-surgery |
The final American Shoulder and Elbow Surgeon (ASES) Score is obtained by summing the pain and functional portions with higher scores indicating better outcomes. |
6 months post-surgery |
|
Primary |
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function at baseline |
A PROMIS score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function, Mobility, and Upper Extremity function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. |
Baseline |
|
Primary |
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function at six months post-surgery |
A PROMIS score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function, Mobility, and Upper Extremity function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. |
6 months post-surgery |
|
Primary |
Single Assessment Numeric Evaluation (SANE) Scores at baseline |
The Single Assessment Numeric Evaluation (SANE) is a patient rating and is The SANE score represents one's perception of shoulder function as a percentage of normal, 0% being no function and 100% being normal function. |
Baseline |
|
Primary |
SANE Scores at six months post-surgery |
The Single Assessment Numeric Evaluation (SANE) is a patient rating and is The SANE score represents one's perception of shoulder function as a percentage of normal, 0% being no function and 100% being normal function. |
6 months post-surgery |
|
Secondary |
Correlation of labral injury and glenohumeral cartilage strain |
The relationship between labral injury and glenohumeral cartilage strain and contact areas will be assessed using images from MRIs. |
Baseline & six months post-surgery |
|
Secondary |
Change in cartilage strain and labrum following surgery |
The relationship between labral injury and glenohumeral cartilage strain and contact areas will be assessed using images from MRIs from pre and post-surgery. |
Six months post-surgery |
|