Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability

Completed

• Conditions: Shoulder Injuries; Instability, Joint; Shoulder Subluxation; Shoulder Dislocation; Glenoid; Dislocation; Anterior Shoulder Instability
• Interventions: Diagnostic Test: MRI

• Registration Number: NCT05431114
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-24
• Study Start: 2022-08-02
• Status Verified: 2025-04
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Shoulder patients	MRI	Participants who presents with glenohumeral instability.

Primary Outcome Measures

Name	Time	Method
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.
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).
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.
Cartilage Strain at baseline	Baseline	Cartilage strain will be assessed using images from MRIs.
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.
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).
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.
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 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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Duke Sports Science Institute; 🇺🇸 Durham, North Carolina, United States