NCT02581358

Use of the Scolioscan for Quantitative Evaluation of Spinal Deformity - A Validity Study on Patients With Scoliosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 952 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 8 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate the validity of Scolioscan for quantitative assessment of curve severity in scoliosis using x-ray radiographs as the gold standard.

Detailed description

Scoliosis is a three dimensional spinal deformity, in both the coronal plane, sagittal and transverse planes. Quantitative assessment of curve severity in scoliosis is important for patient management. At present, Cobb angle measurement in the frontal plane using standing postero-anterior X-ray radiograph is the gold standard for scoliosis evaluation. Taking x-ray involves irradiation and is not without risk especially over repeated exposures for follow-up visits. With advancement of ultrasound technology which is radiation-free and noted to be useful as a tool for musculoskeletal imaging, an ultrasound system designed for evaluation of spinal deformity called Scolioscan has been developed. It comprises of a freehand 3D ultrasound imaging system with an enhanced frame structure for supporting the patient to maintain the posture during scanning and a software for measuring curve deformity in terms of Cobb angles. Previous studies on validity of ultrasound assessment for back deformity involved a pilot group of subjects. Based on these promising pilot results, we plan to carry out a formal study to investigate the validity of Scolioscan for quantitative assessment of curve severity in scoliosis using x-ray radiograph as the gold standard for comparison.

Conditions

• Scoliosis

Interventions

Type	Name	Description
OTHER	Scolioscan (Ultrasound imaging system)	To assess the scoliotic patient, a 3D ultrasound imaging system (the Scolioscan) was developed. The system composes of an ultrasound scanner with a linear probe, a frame structure, an electromagnetic spatial sensing device and a dedicated PC program for imaging and data collection, processing, visualization, analysis, and assessment. The spatial sensor was attached to the ultrasound probe for spatial information collection and calibration. The Scolioscan will generate ultrasound images of the spine for quantitative assessment of the curve deformity in terms of Cobb angles.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2015-10-21
• Last updated: 2020-02-28

Locations

1 site across 1 country: China