NCT06828068

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 442 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: Female
• Age: 8 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Scoliosis
• Spinal Curvatures
• Spinal Diseases
• Bone Diseases
• Musculoskeletal Disease

Interventions

Type	Name	Description
DEVICE	Ultrasound (Scolioscan system), and EOS radiography system	Scolioscan ultrasound system was reported to be reliable and valid for spinal deformity assessment. The system composes of an ultrasound scanner with a linear probe of 10 cm width and frequency range of 4-10MHz, a frame structure and a spatial sensor attached to the ultrasound probe for spatial data capture. Daily calibration will be performed using phantom to assure accuracy of spine image formation and subsequent angle measurement. Subjects will stand on the Scolioscan platform with a standardized posture kept stable with pegs throughout the scanning process. The probe will be steered from L5 to C7 spinous process for scanning. SPA will be used to determine the ultrasound-based Referral Status through predicting whether the Cobb angle is beyond the referral threshold of ≥20° or not. There are two values for the Referral Status: either "for specialist referral" or "not for specialist referral". Coronal Cobb angle measurement on EOS radiographs will be used as gold standard.

Timeline

• Start date: 2018-07-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-02-14
• Last updated: 2026-03-31

Locations

1 site across 1 country: Hong Kong