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

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02581358
• Other study ID #: PhaseIII_V.3
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2017

Study information

• Verified date: February 2020
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 952
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Scoliosis

Intervention

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.

Locations

Country	Name	City	State
China	Department of Orthopaedics and Traumatology, Prince of Wales Hospital	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cobb angle	Curve deformity measurement in terms of Cobb angles assessed by Scolioscan will be correlated with those assessed with conventional x-ray radiographs. The correlation will be compared between: mild and severe curves; thoracic and lumbar curves; low BMI and high BMI subgroups	Baseline