Validation of Scolioscan Air-Portable Radiation-Free Three-Dimensional Ultrasound Imaging Assessment System for Scoliosis

To diagnose scoliosis, the standing radiograph with Cobb’s method is the gold standard for clinical practice. Recently, three-dimensional (3D) ultrasound imaging, which is radiation-free and inexpensive, has been demonstrated to be reliable for the assessment of scoliosis and validated by several groups. A portable 3D ultrasound system for scoliosis assessment is very much demanded, as it can further extend its potential applications for scoliosis screening, diagnosis, monitoring, treatment outcome measurement, and progress prediction. The aim of this study was to investigate the reliability of a newly developed portable 3D ultrasound imaging system, Scolioscan Air, for scoliosis assessment using coronal images it generated. The system was comprised of a handheld probe and tablet PC linking with a USB cable, and the probe further included a palm-sized ultrasound module together with a low-profile optical spatial sensor. A plastic phantom with three different angle structures built-in was used to evaluate the accuracy of measurement by positioning in 10 different orientations. Then, 19 volunteers with scoliosis (13F and 6M; Age: 13.6 ± 3.2 years) with different severity of scoliosis were assessed. Each subject underwent scanning by a commercially available 3D ultrasound imaging system, Scolioscan, and the portable 3D ultrasound imaging system, with the same posture on the same date. The spinal process angles (SPA) were measured in the coronal images formed by both systems and compared with each other. The angle phantom measurement showed the measured angles well agreed with the designed values, 59.7 ± 2.9 vs. 60 degrees, 40.8 ± 1.9 vs. 40 degrees, and 20.9 ± 2.1 vs. 20 degrees. For the subject tests, results demonstrated that there was a very good agreement between the angles obtained by the two systems, with a strong correlation (R2 = 0.78) for the 29 curves measured. The absolute difference between the two data sets was 2.9 ± 1.8 degrees. In addition, there was a small mean difference of 1.2 degrees, and the differences were symmetrically distributed around the mean difference according to the Bland–Altman test. Scolioscan Air was sufficiently comparable to Scolioscan in scoliosis assessment, overcoming the space limitation of Scolioscan and thus providing wider applications. Further studies involving a larger number of subjects are worthwhile to demonstrate its potential clinical values for the management of scoliosis.

[1]  Paolo Pirjanian,et al.  The vSLAM Algorithm for Robust Localization and Mapping , 2005, Proceedings of the 2005 IEEE International Conference on Robotics and Automation.

[2]  Farida Cheriet,et al.  Scoliosis Follow-Up Using Noninvasive Trunk Surface Acquisition , 2013, IEEE Transactions on Biomedical Engineering.

[3]  Marilyn Stovall,et al.  Breast Cancer Mortality After Diagnostic Radiography: Findings From the U.S. Scoliosis Cohort Study , 2000, Spine.

[4]  Viola Bullmann,et al.  Raster Stereography Versus Radiography in the Long-term Follow-up of Idiopathic Scoliosis , 2008, Journal of spinal disorders & techniques.

[5]  Y. Zheng,et al.  Is Radiation-Free Ultrasound Accurate for Quantitative Assessment of Spinal Deformity in Idiopathic Scoliosis (IS): A Detailed Analysis With EOS Radiography on 952 Patients. , 2019, Ultrasound in medicine & biology.

[6]  Rüdiger Krauspe,et al.  Epidemiology of adolescent idiopathic scoliosis , 2013, Journal of children's orthopaedics.

[7]  L. Carreon,et al.  Incidence of cancer in adolescent idiopathic scoliosis patients treated 25 years previously , 2016, European Spine Journal.

[8]  Yan Chen,et al.  High Performance Relaxor-Based Ferroelectric Single Crystals for Ultrasonic Transducer Applications , 2014, Sensors.

[9]  Lin Shi,et al.  Upright, prone, and supine spinal morphology and alignment in adolescent idiopathic scoliosis , 2017, Scoliosis and Spinal Disorders.

[10]  J. M. Carlson,et al.  The prediction of curve progression in untreated idiopathic scoliosis during growth. , 1984, The Journal of bone and joint surgery. American volume.

[11]  Xuelong Li,et al.  Scoliotic Imaging With a Novel Double-Sweep 2.5-Dimensional Extended Field-of-View Ultrasound , 2019, IEEE Transactions on Ultrasonics, Ferroelectrics, and Frequency Control.

[12]  M Kaliszer,et al.  Surface Topography, Cobb Angles, and Cosmetic Change in Scoliosis , 2001, Spine.

[13]  Yong-Ping Zheng,et al.  Ultrasound Volume Projection Imaging for Assessment of Scoliosis , 2015, IEEE Transactions on Medical Imaging.

[14]  Y. Zheng,et al.  A Novel Classification Method for Mild Adolescent Idiopathic Scoliosis Using 3D Ultrasound Imaging , 2021 .

[15]  J. P. Little,et al.  Sequential MRI reveals vertebral body wedging significantly contributes to coronal plane deformity progression in adolescent idiopathic scoliosis during growth , 2020, Spine Deformity.

[16]  Xinhai Lu,et al.  Association Between Incorrect Posture and Adolescent Idiopathic Scoliosis Among Chinese Adolescents: Findings From a Large-Scale Population-Based Study , 2020, Frontiers in Pediatrics.

[17]  Doug Hill,et al.  Reliability of assessing the coronal curvature of children with scoliosis by using ultrasound images , 2013, Journal of children's orthopaedics.

[18]  Stefano Negrini,et al.  Indications for conservative management of scoliosis (guidelines) , 2006, Scoliosis.

[19]  Hana Kim,et al.  Scoliosis Imaging: What Radiologists , 2010 .

[20]  A. Hamzaini,et al.  Association of Cobb angle progression and neuraxial abnormality on MRI in asymptomatic Adolescent Idiopathic Scoliosis. , 2016, The Medical journal of Malaysia.

[21]  Guang-Quan Zhou,et al.  A reliability and validity study for Scolioscan: a radiation-free scoliosis assessment system using 3D ultrasound imaging , 2016, Scoliosis and Spinal Disorders.

[22]  Persistent low-normal bone mineral density in adolescent idiopathic scoliosis with different curve severity: A longitudinal study from presentation to beyond skeletal maturity and peak bone mass. , 2019, Bone.

[23]  W. Skalli,et al.  Quasi-automatic early detection of progressive idiopathic scoliosis from biplanar radiography: a preliminary validation , 2019, European Spine Journal.

[24]  Samer Adeeb,et al.  Monitoring for idiopathic scoliosis curve progression using surface topography asymmetry analysis of the torso in adolescents. , 2015, The spine journal : official journal of the North American Spine Society.

[25]  F. Galbusera,et al.  Is rasterstereography a valid noninvasive method for the screening of juvenile and adolescent idiopathic scoliosis? , 2019, European Spine Journal.

[26]  J. Boice,et al.  Breast cancer in women with scoliosis exposed to multiple diagnostic x rays. , 1989, Journal of the National Cancer Institute.

[27]  Y. Zheng,et al.  3-D measurement of body tissues based on ultrasound images with 3-D spatial information. , 2005, Ultrasound in medicine & biology.

[28]  M Sculpher,et al.  EOS 2D/3D X-ray imaging system: a systematic review and economic evaluation. , 2012, Health technology assessment.

[29]  R. Betz,et al.  Multicenter Comparison of 3D Spinal Measurements Using Surface Topography With Those From Conventional Radiography. , 2016 .

[30]  Jun-lin Yang,et al.  Left Ventricular Mechanics Assessed by 2-dimensional Speckle Tracking Echocardiography in Children and Adolescents With Idiopathic Scoliosis , 2014, Clinical spine surgery.

[31]  Sai Ho Ling,et al.  3D Ultrasound Spine Image Selection Using Convolution Learning-to-Rank Algorithm , 2019, 2019 41st Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC).

[32]  Jing-fan Yang,et al.  Effects of Specific Exercise Therapy on Adolescent Patients with Idiopathic Scoliosis: A Prospective Controlled Cohort Study. , 2020, Spine.

[33]  Y. Zheng,et al.  A Novel Method to Measure the Sagittal Curvature in Spinal Deformities: The Reliability and Feasibility of 3-D Ultrasound Imaging. , 2019, Ultrasound in medicine & biology.

[34]  Carol V. Desain,et al.  Validation for Medical Device and Diagnostic Manufacturers , 1997 .

[35]  Y. Zheng,et al.  Patterns of coronal curve changes in forward bending posture: a 3D ultrasound study of adolescent idiopathic scoliosis patients , 2018, European Spine Journal.

[36]  Christopher M. Mikhail,et al.  Emerging Techniques in Diagnostic Imaging for Idiopathic Scoliosis in Children and Adolescents: A Review of the Literature. , 2020, World neurosurgery.

[37]  Moyo C Kruyt,et al.  A reliability and validity study for different coronal angles using ultrasound imaging in adolescent idiopathic scoliosis. , 2017, The spine journal : official journal of the North American Spine Society.

[38]  Chin Hsia,et al.  A Single-Chip High-Voltage Integrated Actuator for Biomedical Ultrasound Scanners † , 2019, Sensors.

[39]  S. Pflugbeil,et al.  'Lifestyle' and cancer rates in former East and West Germany: the possible contribution of diagnostic radiation exposures. , 2011, Radiation protection dosimetry.

[40]  James H. Stephen,et al.  Evaluation and management of adolescent idiopathic scoliosis: a review. , 2017, Neurosurgical focus.

[41]  T. Grivas,et al.  Pulmonary function in children with idiopathic scoliosis , 2012, Scoliosis.

[42]  H. Kauczor,et al.  3D-modeling of the spine using EOS imaging system: Inter-reader reproducibility and reliability , 2017, PloS one.

[43]  X. Cui,et al.  Ultrasound Image Optimization (“Knobology”): B-Mode , 2020, Ultrasound International Open.

[44]  P. Soucacos,et al.  Assessment of curve progression in idiopathic scoliosis , 1998, European Spine Journal.

[45]  J E Hall,et al.  Current treatment approaches in the nonoperative and operative management of adolescent idiopathic scoliosis. , 1991, Physical therapy.

[46]  K. Luk,et al.  Adolescent idiopathic scoliosis , 2015, Nature Reviews Disease Primers.

[47]  Andras Lasso,et al.  Spinal curvature measurement by tracked ultrasound snapshots. , 2014, Ultrasound in medicine & biology.

[48]  J. Bettany-Saltikov,et al.  Imaging in the Diagnosis and Monitoring of Children with Idiopathic Scoliosis , 2017, The open orthopaedics journal.

[49]  Yong-Ping Zheng,et al.  Development of 3-D ultrasound system for assessment of adolescent idiopathic scoliosis (AIS): And system validation , 2013, 2013 35th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC).

[50]  R. Winter,et al.  Adolescent idiopathic scoliosis , 1991, The Lancet.

[51]  H. Yoshikawa,et al.  In vivo three-dimensional segmental analysis of adolescent idiopathic scoliosis , 2011, European Spine Journal.

[52]  J Persliden,et al.  Digital radiography of scoliosis with a scanning method: initial evaluation. , 2001, Radiology.

[53]  Rui Zheng,et al.  Compact and Wireless Freehand 3D Ultrasound Real-time Spine Imaging System: A pilot study , 2020, 2020 42nd Annual International Conference of the IEEE Engineering in Medicine & Biology Society (EMBC).

[54]  Y. Zheng,et al.  Could clinical ultrasound improve the fitting of spinal orthosis for the patients with AIS? , 2012, European Spine Journal.

[55]  Guang-Quan Zhou,et al.  Freehand three-dimensional ultrasound system for assessment of scoliosis , 2015, Journal of orthopaedic translation.

[56]  Jin-Suck Suh,et al.  Scoliosis imaging: what radiologists should know. , 2010, Radiographics : a review publication of the Radiological Society of North America, Inc.

[57]  B. Dawson-Saunders,et al.  Basic and Clinical Biostatistics , 1993 .

[58]  J. Hanley,et al.  Projecting the lifetime risk of cancer from exposure to diagnostic ionizing radiation for adolescent idiopathic scoliosis. , 1994, Health physics.

[59]  J. Yip,et al.  School scoliosis screening in Hong Kong: trunk asymmetry of girls with scoliosis , 2020 .

[60]  Y. Zheng,et al.  Cross-validation of ultrasound imaging in adolescent idiopathic scoliosis , 2020, European Spine Journal.

[61]  M. Li,et al.  A Preliminary Study of Estimation of Cobb’s Angle From the Spinous Process Angle Using a Clinical Ultrasound Method , 2015, Spine deformity.

[62]  K. Luk,et al.  A population-based cohort study of 394,401 children followed for 10 years exhibits sustained effectiveness of scoliosis screening. , 2015, The spine journal : official journal of the North American Spine Society.

[63]  J. Cobb The problem of the primary curve. , 1960, The Journal of bone and joint surgery. American volume.

[64]  N. Boutry,et al.  Idiopathic scoliosis in children and adolescents: assessment with a biplanar X-ray device , 2014, Insights into Imaging.

[65]  Q H Huang,et al.  Development of a portable 3D ultrasound imaging system for musculoskeletal tissues. , 2005, Ultrasonics.

[66]  J. Callaghan,et al.  Increasing Hospital Charges for Adolescent Idiopathic Scoliosis in the United States , 2014, Spine.

[67]  T Yamamuro,et al.  Ultrasound measurement of vertebral rotation in idiopathic scoliosis. , 1989, The Journal of bone and joint surgery. British volume.