Using Radiation-free Ultrasound for Screening Scoliosis Among Female School Children in Hong Kong to Reduce Unnecessary X-ray Exposure

Last updated: February 11, 2025
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bone Diseases

Musculoskeletal Diseases

Treatment

Ultrasound (Scolioscan system), and EOS radiography system

Clinical Study ID

NCT06828068
SScoE_Protocol_V01
Project no: 04152896
  • Ages 8-14
  • Female

Study Summary

In the scoliosis screening program of the Student Health Service (SHS), Department of Health (DH), in Hong Kong, more than 50% of screened school children prescribed with x-ray examination basing on the screening protocol did not have Cobb angle greater than the referral threshold of 20°; ie they did not need specialist referral and thus were subjected to unnecessary x-ray exposure. Our primary objective is to determine whether a new radiation-free ultrasound system could identify subjects with Cobb angle greater than the referral threshold of 20° thus avoiding unnecessary x-rays in the referral workflow. The secondary objective is to evaluate if Angle of Trunk Rotation (ATR) can further increase the accuracy of ultrasound assessment.

This study is an extension of the registered project entitled "Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure", (ClinicalTrials.gov Identifier: NCT03135665), however focusing on validity of ultrasound measurement for immature female subjects aged around ten with year since menarche equal to or less than 9 months, who are prone to curve progression, and thus are among the most critical group in clinical management of scoliosis for regular monitoring, treatment decision, and brace indication.

Eligibility Criteria

Inclusion

Inclusion Criteria:

i. School children in Hong Kong attending School Screening Program provided by Student Health Service ii. Recommended for radiographic assessment in the scoliosis screening program iii. Female with year since menarche of equal to or less than 9 months

Exclusion

Exclusion Criteria:

i. Patients with standing height <1 m, or >2 m ii. Patients with body mass index (BMI) ≥25 kg/m2 iii. Subjects with skin diseases iv. Subjects with fracture or wound that affect ultrasound scanning v. Subjects with ferromagnetic implants vi. Subjects with surgery done for the spine vii. Subjects with winged scapula or other irregularity of back contour that affect ultrasound scanning viii. Subjects who cannot stand steadily during scanning ix. Subjects with allergy to ultrasound gel

Study Design

Total Participants: 442
Treatment Group(s): 1
Primary Treatment: Ultrasound (Scolioscan system), and EOS radiography system
Phase:
Study Start date:
July 01, 2018
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • The Chinese University of Hong Kong

    Hong Kong,
    Hong Kong

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.