Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability (OREF)

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

Study Overview

• Status: Recruiting
• Conditions: Shoulder Injuries; Anterior Shoulder Instability; Shoulder Dislocation; Instability, Joint; Shoulder Subluxation; Glenoid; Dislocation
• Intervention / Treatment: Diagnostic test: MRI

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Duke Sports Medicine Research; Phone Number: 919-66-09371; Email: sportsmed_research@dm.duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke Sports Science Institute
      • Principal Investigator: Brian Lau, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of individuals ages 18 to 50 years old, who have sustained an anterior shoulder dislocation that requires surgical intervention.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Shoulder patients; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Brian Lau, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Shoulder; Glenoid; Arthroscopy; Acute; Dislocation; Instability
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Shoulder Injuries; Joint Instability; Shoulder Dislocation
• Other Study ID Numbers: Pro00110036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No