The study examines whether a mechanical arm ultrasound system provides diagnostic accuracy comparable to expert-performed full ultrasound for detecting key joint components and whether it can reduce acquisition variability without compromising accuracy, as measured by false-positive and false-negative rates.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
11
3D ultrasound imaging is a non-invasive technique. The device consists of a stationary platform and a water-filled rotating drum designed to acquire 3D ultrasound images of the ankles. An ultrasound transducer is mounted on a mechanical arm, which positions and orients it toward the rotating axis of the drum. The collected ultrasound images will be mapped into 3D space, and the volume will be reconstructed using software developed by the manufacturer.
1. Diagnostic Accuracy of 3DUS compared with full ultrasound and MRI
Proportion of correctly classified cases comparing 3DUS findings against full ultrasoind and MRI (reference standard)
Time frame: Day 1
Ability of 3DUS to quantify individual joint components (synovial hypertrophy, hemarthrosis, hemosiderin, bone erosions/subchondral cysts, cartilage loss)
Findings will be measured as normal, mild, moderate and severe
Time frame: Day 1
Integration of 3D ultrasound into Diagnostic Algorithm
Number of cases where 3DUS prevents the need for MRI or full ultrasound or improves detection of early arthropathy.
Time frame: Day 1
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