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 range18 Years – 50 Years

SexALL

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

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

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

Timeframe: 6 months post-surgery

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 range18 Years – 50 Years

SexALL

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

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

Timeframe: 6 months post-surgery