Clinical trial NCT05431114: Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability
Official title: Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Instability, Joint
Shoulder Dislocation
Shoulder Injuries
Shoulder Subluxation
Anterior Shoulder Instability
Glenoid; Dislocation
Keywords: Instability
Shoulder
Dislocation
Glenoid
Acute
Arthroscopy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Cartilage Strain at baseline
timeFrame: Baseline
measure: Cartilage Strain at baseline at six months post-surgery
timeFrame: 6 months post-surgery
measure: Western Ontario Shoulder Instability Index (WOSI) at baseline
timeFrame: Baseline
measure: Western Ontario Shoulder Instability Index (WOSI) at six months post-surgery
timeFrame: 6 months post-surgery
measure: American Shoulder and Elbow Surgeon (ASES) Score at baseline
timeFrame: Baseline
measure: American Shoulder and Elbow Surgeon (ASES) Score at six months post-surgery
timeFrame: 6 months post-surgery
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) physical function at baseline
timeFrame: Baseline
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) physical function at six months post-surgery
timeFrame: 6 months post-surgery
measure: Single Assessment Numeric Evaluation (SANE) Scores at baseline
timeFrame: Baseline
measure: SANE Scores at six months post-surgery
timeFrame: 6 months post-surgery
Secondary outcomes:
measure: Correlation of labral injury and glenohumeral cartilage strain
timeFrame: Baseline & six months post-surgery
measure: Change in cartilage strain and labrum following surgery
timeFrame: Six months post-surgery
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Sports Science Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Brian Lau, MD
role: PRINCIPAL_INVESTIGATOR
References: