Applicability of 3T Shoulder MRI in Detection of Labral Pathology
- Conditions
- Labral Tear, Glenoid
- Interventions
- Radiation: 1.5 Tesla magnet MR arthrographyRadiation: 3 Tesla magnet non-contrast MRI
- Registration Number
- NCT06043791
- Lead Sponsor
- Henry Ford Health System
- Brief Summary
The purpose of this observational study is to compare image quality between 3 Tesla magnet (3T) non-contrast MRI to the current standard of MR arthrogram (1.5T magnet) in detecting shoulder labral and cartilage pathology.
An orthopedic surgeon on the research team will screen for patients with high probability of labral and/or cartilaginous pathology and the need for advanced imaging. The orthopedic surgeon's inclusion of patients will be based on a thorough clinical exam and obtained history. Patients included in the study will be imaged using both protocols - the current standard of MR arthrogram with a 1.5T magnet and non-contrast imaging with a 3T magnet. Both sets of images will be interpreted by multiple fellowship-trained musculoskeletal radiologists for adequate intra and inter-rater reliability.
- Detailed Description
The specific aim of this investigation is to determine the accuracy and reliability of 3T MRI in the detection of shoulder labral and cartilage pathology as compared to the current standard of MR arthrography with a 1.5T magnet scanner.
Patients who present to a Henry Ford orthopedic clinic associated with a surgeon participating in this study and are indicated for labral surgery will be assessed for eligibility. Patients will be interviewed, and their medical chart reviewed to determine whether they meet inclusion and exclusion criteria. Sections of the medical chart that will be reviewed include history of present illness, medical and surgical history, and the physical exam. Patients who meet criteria for this study will be consented by the surgeon or other key study personnel. A password-protected spreadsheet stored on Henry Ford OneDrive will be used to track patients enrolled in the study and make record of patients who do not meet inclusion criteria.
Patients between 14-65 years of age being seen in orthopedic clinic with shoulder pathology likely requiring surgical intervention will be screened into the study. Patients will be imaged with standard of care MRI shoulder arthrogram on a 1.5 T magnet and additionally with non-contrast MRI of the shoulder on a 3 T magnet. All patients will be dually imaged. Initial imaging will utilize the standard of care, and, subsequently, patients will be brought back within 2 weeks, for non-contrast MRI as part of the study protocol. Both sets of images will be interpreted by multiple fellowship-trained musculoskeletal radiologists for adequate intra and inter-rater reliability.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 78
- Indicated for likely labral surgery
- Chronic, degenerative labral and/or cartilage pathology
- Ability to read and understand English
- Age ≥ 18 years
- Age ≤ 65 years
- Patient does not complete both the MR arthrogram and 3T non-contrast MRI
- Unexpected trauma in between the MR arthrogram and 3T non-contrast MRI
- Age < 18 years
- Age > 65 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment 3 Tesla magnet non-contrast MRI Patients will be imaged with standard of care MRI shoulder arthrogram on a 1.5 T magnet and additionally with non-contrast MRI of the shoulder on a 3 T magnet. All patients will be dually imaged. Initial imaging will utilize the standard of care, and, subsequently, patients will be brought back within 2 weeks, for non-contrast MRI as part of the study protocol Treatment 1.5 Tesla magnet MR arthrography Patients will be imaged with standard of care MRI shoulder arthrogram on a 1.5 T magnet and additionally with non-contrast MRI of the shoulder on a 3 T magnet. All patients will be dually imaged. Initial imaging will utilize the standard of care, and, subsequently, patients will be brought back within 2 weeks, for non-contrast MRI as part of the study protocol
- Primary Outcome Measures
Name Time Method Quantitative Assessment of Labral Tear Detection: 3T Non-contrast MRI vs. MRA 1 week Consistent diagnosis of labral tear in both imaging modalities done by fellowship-trained radiologists
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Henry Ford Health
🇺🇸Royal Oak, Michigan, United States