Anterior Shoulder Instability, Glenoid; Dislocation, Instability, Joint, Shoulder Dislocation, Shoulder Injuries, Shoulder Subluxation
Conditions
Keywords
Instability, Shoulder, Dislocation, Glenoid, Acute, Arthroscopy
Brief summary
The purpose of this study is to assess cartilage strain and contact areas following glenohumeral instability compared to healthy individuals.
Detailed description
The purpose of this study is to assess cartilage strain and contact areas following glenohumeral instability compared to healthy individuals. This is a prospective longitudinal cohort study to investigate cartilage strain and labral injury utilizing advance MRI techniques. Patients with shoulder instability will be studied at baseline (after injury and prior to surgical treatment) with glenohumeral cartilage strain MRI protocol, pre and post exercise. Patient reported outcomes including Western Ontario Shoulder Instability Index (WOSI), American Shoulder and Elbow Surgeon (ASES) Score, and PROMIS physical function and pain scores, will also be evaluated. Data from this study will be compared to a previous study involving healthy controls that underwent the same exercises and imaging.
Interventions
DIAGNOSTIC_TESTMRI
Images of the injured shoulder will then be taken with magnetic resonance (MR) scanner. MRIs of each participant's shoulder will be acquired before and after completion of an exercise protocol.
Sponsors
Duke University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Males and females ≥ 18 years old and ≤ 50 years old * Acute injury involving anterior (front) shoulder dislocation * Willingness to undergo arthroscopic shoulder stabilization * Willingness to participant in standard rehabilitation
Exclusion criteria
* Moderate to severe osteoarthritis prior to surgery * Will undergo bony augmentation to glenoid or humerus in addition to shoulder stabilization * Unable to undergo standard pre and post-injury/operative rehabilitation * History of inflammatory arthritis * Previous surgery of the injured shoulder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SANE Scores at six months post-surgery | 6 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. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) physical function at six months post-surgery | 6 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. |
| Single Assessment Numeric Evaluation (SANE) Scores at baseline | 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. |
| Cartilage Strain at baseline | Baseline | Cartilage strain will be assessed using images from MRIs. |
| Cartilage Strain at baseline at six months post-surgery | 6 months post-surgery | Cartilage strain will be assessed using images from MRIs. |
| Western Ontario Shoulder Instability Index (WOSI) at baseline | 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). |
| Western Ontario Shoulder Instability Index (WOSI) at six months post-surgery | 6 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). |
| American Shoulder and Elbow Surgeon (ASES) Score at baseline | 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. |
| American Shoulder and Elbow Surgeon (ASES) Score at six months post-surgery | 6 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. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) physical function at baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cartilage strain and labrum following surgery | Six months post-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. |
| Correlation of labral injury and glenohumeral cartilage strain | Baseline & six months post-surgery | The relationship between labral injury and glenohumeral cartilage strain and contact areas will be assessed using images from MRIs. |
Countries
United States
Outcome results
None listed