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

NCT02581358 | Completed

• 1 other identifier: PhaseIII_V.3
• Study Type: interventional
• Target: 952
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Scoliosis

Keywords

scoliosis; spinal deformity; Cobb angle; assessment; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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: 1. mild and severe curves 2. thoracic and lumbar curves 3. low BMI and high BMI subgroups

  Baseline

Study Arms (1)

Scolioscan (Ultrasound imaging system)

EXPERIMENTAL

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

Other: Scolioscan (Ultrasound imaging system)

Interventions

Scolioscan (Ultrasound imaging system) OTHER

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.

Scolioscan (Ultrasound imaging system)

Eligibility Criteria

• Age: 8 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Orthopaedics and Traumatology, Prince of Wales Hospital

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Tsz Ping Lam

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Clinical)

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 21, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

CN (1)