Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability

Shoulder Dislocation Clinical Trial

— OREF  

Official title:

Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431114
• Other study ID #: Pro00110036
• Status: Recruiting
• Start date: August 2, 2022
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Duke University
• Contact: Duke Sports Medicine Research
• Phone: 919-66-09371
• Email: sportsmed_research[@]dm.duke.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Shoulder Instability
• Instability, Joint
• Joint Instability
• Shoulder Dislocation
• Shoulder Injuries
• Shoulder Subluxation

Intervention

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.

Locations

Country	Name	City	State
United States	Duke Sports Science Institute	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

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