Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability

Study Overview
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Brief Summary
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The purpose of this study is to assess cartilage strain and contact areas following glenohumeral instability compared to healthy individuals.

Detailed Description
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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.

Official Title
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Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability

Conditions
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Instability, Joint, Shoulder Dislocation, Shoulder Injuries, Shoulder Subluxation, Anterior Shoulder Instability, Glenoid; Dislocation

Intervention / Treatment
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* Diagnostic Test: MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Shoulder patients<br>Participants who presents with glenohumeral instability. | Diagnostic Test: MRI<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cartilage Strain at baseline | Cartilage strain will be assessed using images from MRIs. | Baseline | 
| Cartilage Strain at baseline at six months post-surgery | Cartilage strain will be assessed using images from MRIs. | 6 months post-surgery | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Instability, Shoulder, Dislocation, Glenoid, Acute, Arthroscopy