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

The Chinese University of Hong Kong

Status: Completed

Conditions: Scoliosis

Treatments: Other: Scolioscan (Ultrasound imaging system)

Study type: Interventional

Funder types: Other

Identifiers

NCT02581358

PhaseIII_V.3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 952 patients

Sex: All

Ages: 8 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scoliosis patients between 8-40 years old
• Patients with body mass index (BMI) <23 kg/m2
• Patients with standing height between 1 m - 2 m

Exclusion criteria

• Pregnant women or women after pregnancy before return of the menstrual period.
• Subjects with skin disease such as skin cancer, psoriasis or a history of skin disease
• Subjects with fracture or wound that affect application of the probe of Scolioscan during scanning
• Subjects with Ferromagnetic implants
• Subjects with pacemakers, implanted pain modulators, implanted insulin delivery systems, cochlear implant, and any defibrillator
• Subjects with surgery done for the spine
• Subjects with winged scapula or other irregularity of back contour that precludes satisfactory skin contact of the machine probe during the scanning procedure
• Subjects who cannot stand steadily on the device during the examination
• Subjects with allergy to aqueous gel used for ultrasound scanning

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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952 participants in 1 patient group

Scolioscan (Ultrasound imaging system)

Experimental group

Description:

This diagnostic study is a single arm study with all participants receiving investigation with the Scolioscan (a diagnostic ultrasound machine) for quantitative assessment of spinal deformity

Treatment:

Other: Scolioscan (Ultrasound imaging system)