CompletedNot Applicable

Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability

United States20 participantsStarted 2022-08-02

Plain-language summary

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

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cartilage Strain at baseline

Timeframe: Baseline

Cartilage Strain at baseline at six months post-surgery

Timeframe: 6 months post-surgery

Western Ontario Shoulder Instability Index (WOSI) at baseline

Timeframe: Baseline

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

Timeframe: 6 months post-surgery

American Shoulder and Elbow Surgeon (ASES) Score at baseline

Timeframe: Baseline

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

Timeframe: 6 months post-surgery

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

Timeframe: Baseline

Trial details

NCT IDNCT05431114

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-04-01

View on ClinicalTrials.gov More Instability, Joint trials

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cartilage Strain at baseline

Timeframe: Baseline

Cartilage Strain at baseline at six months post-surgery

Timeframe: 6 months post-surgery

Western Ontario Shoulder Instability Index (WOSI) at baseline

Timeframe: Baseline

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

Timeframe: 6 months post-surgery

American Shoulder and Elbow Surgeon (ASES) Score at baseline

Timeframe: Baseline

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

Timeframe: 6 months post-surgery

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

Timeframe: Baseline