Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability

NCT05431114 | Completed DMC

• 1 other identifier: Pro00110036
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Instability; Shoulder; Dislocation; Glenoid; Acute; Arthroscopy

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (2)

• Correlation of labral injury and glenohumeral cartilage strain

  Baseline & six months post-surgery

• Change in cartilage strain and labrum following surgery

  Six months post-surgery

Study Arms (1)

Shoulder patients

Participants who presents with glenohumeral instability.

Diagnostic Test: MRI

Interventions

MRI 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.

Shoulder patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Sports Science Institute

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Joint Instability; Shoulder Dislocation; Shoulder Injuries; Joint Dislocations

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Officials

• Brian Lau, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 24, 2022
• Study Start: August 2, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)