MRI arthrography of the shoulder, MRA shoulder Magnetic resonance imaging of the shoulder using contrast
Conditions
Interventions
Subjects are referred for MRA shoulder and randomly receive an intra-articular injection of saline, saline and lidocaine, or gadolinium in the shoulder. After the injection, MRA of the shoulder will b
Sponsors
Treant
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients referred for shoulder MRI arthrography18 years or older.
Exclusion criteria
Exclusion criteria: Patients with contraindications to MRI (i.e., pacemakers or metallic implants).Patients with known allergies to gadolinium or lidocaine.Patients who are not familiar with the Dutch languagePatients with a mental deficiencyPatients who underwent shoulder surgery less than two weeks prior to referral for shoulder MRA.Distinctive abnormalities or pathologies in the MRI exam (either prospective or retrospective)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to compare the image quality of saline-enhanced shoulder MRI arthrography with that of gadolinium-enhanced shoulder MRI arthrography, using qualitative and quantitative variables. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient comfort will be assessed using the Numerical Rating Scale (NRS), with 1 indicating no pain and 10 indicating the most intolerable pain possible. Patients will be asked before the intra-articular injection, after the intra-articular injection, and after the MRI examination. The motion artifacts in the examinations will be determined using a still-to-be-determined parameter. Determining the diagnostic accuracy (sensitivity and specificity) for detecting labral tears, rotator cuff tears, and other intra-articular pathologies, as confirmed by arthroscopy or surgery.Exploratory objectivesInjected volume in relation to the Likert scoresScores on the necessity of an intra-articular contrast agent: yes or no.Train an artificial intelligence model (AI) in image recognition and segmentation to reproduce Likert scores and measurements. | — |
Countries
Netherlands
Contacts
Public ContactA Vegter
Treant
Outcome results
None listed