Validation of a novel handheld 3D ultrasound system for imaging scoliosis - phantom study.

Use of 3D ultrasound (US) scanners to detect and monitor scoliosis have been validated. The Cobb angle, axial vertebral rotation, spinal flexibility, curvatures in the sagittal profile and the Cobb angle on the plane of maximum curvature (PMC) can be measured from coronal, transverse and sagittal planes of ultrasound images. However, traditional 3D ultrasound scanners are relatively bulky and expensive. 2D US handheld and low-cost scanners are widely available. To adapt the 2D scanners for scoliosis applications, a position and orientation system is integrated with the scanner. The objective of this study was to validate a newly developed 3D handheld US system to image the spine. The wireless handheld US scanner (C3-HD, Clarius, Canada) was selected because of its high resolution and availability of raw data. A wireless tracking system based on electromagnetic (G4 system, Polhemus, USA) was integrated with the Clarius ultrasound. During scanning, the ultrasound information was synchronized with the scanner's position and orientation by using custom developed software. Both information were streamed wirelessly to a laptop. Custom software reconstructed and displayed the 3D spinal image in real-time. A single 3D printed vertebra, two full plastic spine phantoms from T1-T12 vertebrae and a non-scoliotic volunteer were scanned. The 3D reconstruction process of a spine image was less than 3 seconds. The dimensional and the angle errors were 1 mm and 3°, respectively. This study demonstrated that a low-cost ($11,000 USD) handheld 3D ultrasound system was developed and validated. Clinical trials on subjects attending will be the next step.