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Completed

NCT Number: NCT05431114

Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability

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

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Key information

Conditions

Instability, Joint Anterior Shoulder Instability Glenoid; Dislocation Joint Diseases Joint Dislocations Joint Instability Musculoskeletal Diseases Shoulder Dislocation Shoulder Injuries Shoulder Subluxation Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke Sports Science Institute

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Cartilage Strain at baseline

    Time frame: Baseline

    Cartilage strain will be assessed using images from MRIs.

  2. Cartilage Strain at baseline at six months post-surgery

    Time frame: 6 months post-surgery

    Cartilage strain will be assessed using images from MRIs.

  3. Western Ontario Shoulder Instability Index (WOSI) at baseline

    Time frame: 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).

  4. Western Ontario Shoulder Instability Index (WOSI) at six months post-surgery

    Time frame: 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).

  5. American Shoulder and Elbow Surgeon (ASES) Score at baseline

    Time frame: 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.

  6. American Shoulder and Elbow Surgeon (ASES) Score at six months post-surgery

    Time frame: 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.

  7. Patient-Reported Outcomes Measurement Information System (PROMIS) physical function at baseline

    Time frame: 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.

  8. Patient-Reported Outcomes Measurement Information System (PROMIS) physical function at six months post-surgery

    Time frame: 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.

  9. Single Assessment Numeric Evaluation (SANE) Scores at baseline

    Time frame: 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.

  10. SANE Scores at six months post-surgery

    Time frame: 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.

Secondary outcomes

  1. Correlation of labral injury and glenohumeral cartilage strain

    Time frame: Baseline & six months post-surgery

    The relationship between labral injury and glenohumeral cartilage strain and contact areas will be assessed using images from MRIs.

  2. Change in cartilage strain and labrum following surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: OREF

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2022
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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