Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device

The POROUS R3C ultrasound device measures the cortical bone of the midshaft tibia. Ultrasound gel is first applied onto the skin surface, covering the region of interest, followed by placing the ultrasound transducer with a medical ultrasound gel pad placed in front of it. At the marked position on the leg, four technical measurement readings are performed: 2x CortBS and 2x Multifocus, with repositioning the probe between individual measurements, the chronological order of which is not crucial. Scanning time for each measurement takes 1-2 minutes. Out of the four measurements, the two optimal measurements (one for CortBS and one for Multifocus) are selected by the device, based on pre-defined quality criteria.

"The following DXA measurements are to be performed:~* Spine L1-4~* Hip left~* Hip right (alternatively, if a valid measurement of the left hip is not possible) Scanning takes approximately 15 minutes. A maximum number of one repeat measurement is planned (e.g., hip or spine). Note: The DXA scan of the hip is performed on the same side of the body as the POROUS R3C ultrasound scan."

DXA-based Vertebral Fracture Assessment (VFA) of thoracic and lumbar spine from T4 to L5.

Projectional radiography of thoracic spine T4-T12 and lumbar spine L1-L5.