An observational study in Instability, Joint, Shoulder Dislocation and Shoulder Injuries, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Duke University · Observational
The purpose of this study is to assess cartilage strain and contact areas following glenohumeral instability compared to healthy individuals.
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.
115 studies on the registry are indexed under Joint Instability; 21 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 54 observational studies indexed under Joint Instability.
Browse Joint Instability studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
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The study population will consist of individuals ages 18 to 50 years old, who have sustained an anterior shoulder dislocation that requires surgical intervention.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants who presents with glenohumeral instability.
Diagnostic Test: MRI
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.
Cartilage Strain at baseline
Cartilage strain will be assessed using images from MRIs.
Time frame: Baseline
Cartilage Strain at baseline at six months post-surgery
Cartilage strain will be assessed using images from MRIs.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months post-surgery
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.
Time frame: 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.
Time frame: Six months post-surgery
Plan to share: No
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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