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

Not Applicable

Completed

• Conditions: Scoliosis
• Interventions: Device: Ultrasound

• Registration Number: NCT03135665
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-05-01
• Study Start: 2017-09-18
• Primary Completion: 2018-11-30
• Study Completion: 2019-05-31
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

Inclusion Criteria

i. Schoolchildren in Hong Kong attending School Screening Program provided by Student Health Service ii. Recommended for radiographic assessment in the scoliosis screening program

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ScoE	Ultrasound	This is a cross-sectional study on screened school children recommended for radiographic assessment in the scoliosis screening program of SHS in Hong Kong. Both x-ray, ultrasound and ATR measurement of the spine will be performed on the same day at Prince of Wales Hospital.

Primary Outcome Measures

Name	Time	Method
ultrasound-based Referral Status	Baseline	"for specialist referral" or "not for specialist referral", through predicting whether the Cobb angle is beyond the referral threshold of ≥20° or not in scoliosis screening

Secondary Outcome Measures

Name	Time	Method
ATR	Baseline	evaluate if this parameter can increase the accuracy of ultrasound assessment

Trial Locations

Locations (1)

Department of Orthopaedics and Traumatology, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong