Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability

NCT ID: NCT05431114

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2025-04-01

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Shoulder patients

Participants who presents with glenohumeral instability.

MRI

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Lau, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Sports Science Institute

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00110036

Identifier Type: -

Identifier Source: org_study_id