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

February 27, 2020 updated by: Tsz-ping Lam, Chinese University of Hong Kong
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

952

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Department of Orthopaedics and Traumatology, Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Scolioscan (Ultrasound imaging system)
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cobb angle
Time Frame: Baseline

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Tsz Ping Lam, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 19, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (Estimate)

October 21, 2015

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhaseIII_V.3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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