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

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135665
• Other study ID #: ScoE_Protocol_V04
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: December 2019
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: May 31, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Scoliosis

Intervention

Device:
• Ultrasound
Scolioscan, the ultrasound system reported to be reliable and valid for spinal deformity assessment, will be used. The system composes of an ultrasound scanner with a linear probe of 100 mm in width and frequency range of 4-10MHz, a frame structure and a spatial sensor which is attached to the ultrasound probe for spatial data capture. Daily calibration will be performed using a 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.. After adjusting the ultrasound scanner setting, the probe will be steered from L5 to T1 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".

Locations

Country	Name	City	State
Hong Kong	Department of Orthopaedics and Traumatology, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (23)

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Cheung CW, Zhou GQ, Law SY, Mak TM, Lai KL, Zheng YP. Ultrasound Volume Projection Imaging for Assessment of Scoliosis. IEEE Trans Med Imaging. 2015 Aug;34(8):1760-8. doi: 10.1109/TMI.2015.2390233. Epub 2015 Jan 12. — View Citation

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Fong DY, Lee CF, Cheung KM, Cheng JC, Ng BK, Lam TP, Mak KH, Yip PS, Luk KD. A meta-analysis of the clinical effectiveness of school scoliosis screening. Spine (Phila Pa 1976). 2010 May 1;35(10):1061-71. doi: 10.1097/BRS.0b013e3181bcc835. Review. — View Citation

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Lee CF, Fong DY, Cheung KM, Cheng JC, Ng BK, Lam TP, Mak KH, Yip PS, Luk KD. Referral criteria for school scoliosis screening: assessment and recommendations based on a large longitudinally followed cohort. Spine (Phila Pa 1976). 2010 Dec 1;35(25):E1492-8. doi: 10.1097/BRS.0b013e3181ecf3fe. — View Citation

Li M, Cheng J, Ying M, Ng B, Lam TP, Wong MS. A Preliminary Study of Estimation of Cobb's Angle From the Spinous Process Angle Using a Clinical Ultrasound Method. Spine Deform. 2015 Sep;3(5):476-482. doi: 10.1016/j.jspd.2015.03.001. Epub 2015 Oct 2. — View Citation

Li M, Cheng J, Ying M, Ng B, Zheng YP, Lam TP, Wong WY, Wong MS. Could clinical ultrasound improve the fitting of spinal orthosis for the patients with AIS? Eur Spine J. 2012 Oct;21(10):1926-35. doi: 10.1007/s00586-012-2273-4. Epub 2012 Mar 25. — View Citation

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Luk KD, Lee CF, Cheung KM, Cheng JC, Ng BK, Lam TP, Mak KH, Yip PS, Fong DY. Clinical effectiveness of school screening for adolescent idiopathic scoliosis: a large population-based retrospective cohort study. Spine (Phila Pa 1976). 2010 Aug 1;35(17):1607-14. doi: 10.1097/BRS.0b013e3181c7cb8c. — View Citation

Morrison DG, Chan A, Hill D, Parent EC, Lou EH. Correlation between Cobb angle, spinous process angle (SPA) and apical vertebrae rotation (AVR) on posteroanterior radiographs in adolescent idiopathic scoliosis (AIS). Eur Spine J. 2015 Feb;24(2):306-12. doi: 10.1007/s00586-014-3684-1. Epub 2014 Nov 21. — View Citation

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Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19. — View Citation

Zheng YP, Lee TT, Lai KK, Yip BH, Zhou GQ, Jiang WW, Cheung JC, Wong MS, Ng BK, Cheng JC, Lam TP. A reliability and validity study for Scolioscan: a radiation-free scoliosis assessment system using 3D ultrasound imaging. Scoliosis Spinal Disord. 2016 May 31;11:13. doi: 10.1186/s13013-016-0074-y. eCollection 2016. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ultrasound-based Referral Status	"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	Baseline
Secondary	ATR	evaluate if this parameter can increase the accuracy of ultrasound assessment	Baseline