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Trial History Detail on 2017-04-13

CUHK_CCRB00552

2017-04-13

Prospective

ScoE_Protocol_V01

Health and Medical Research Fund

Health and Medical Research Fund

N/A

Not Applicable

Lyn Wong

5/F, Lui Che Woo Clinical Science Building,
Prince of Wales Hospital,
Shatin, Hong Kong

26323309

lynwong@cuhk.edu.hk

Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong

Hong Kong

Prof. Lam Tsz Ping

5/F, Lui Che Woo Clinical Science Building,
Prince of Wales Hospital,
Shatin, Hong Kong

26323309

b132720@mailserv.cuhk.edu.hk

Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong

Hong Kong

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

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

為香港學童評估無輻射超聲波脊柱側彎篩選檢查, 以減少對學童不必要的X光照射

ScoE

Hong Kong

Yes

2016-12-06

Joint CUHK-NTEC Clinical Research Ethics Committee

2016.658

Scoliosis

Device

Subjects seen at Student Health Service will be invited to participate in the study to be carried out at Prince of Wales Hospital. Ethical approval will be obtained separately from the joint CUHK-NTEC Clinical Research Ethics Committee and Department of Health before study implementation. Subjects and their guardians will be given detailed explanation of the study. Questions will be answered up to their satisfaction. A written informed consent from the subjects and their guardians will be obtained before investigations are carried out.

A. Ultrasound measurement
Scolioscan, the ultrasound system reported to be reliable and valid for spinal deformity assessment, will be used[23]. 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. Ultrasound frequency will be set to 7.5 MHz, the focus and scanning depth will be set at 3.5 and 7.1 cm respectively. After adjusting the ultrasound scanner setting, the probe will be steered from L5 to T1 spinous process for scanning.
Details of ultrasound assessment, measurement of SPA and its correlation with Cobb angle have been described in the “Introduction” session. 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”.

B. Radiographic examination with the EOS system
Postero-anterior standing views of the whole spine will be taken out of brace using the EOS radiographic system according to a standard protocol. Subjects stand with shoulders in forward flexion at 90 degrees and forearms kept in vertical position and hands fisted. Respiration will be kept as shallow as possible during EOS scanning. Spinal curvatures on the x-ray images will be identified and its severity will be assessed with the Cobb Method to measure the Cobb angle for each structural curve[1]. Curve types will be determined according to the SRS classification[25].

C. Clinical assessment and examination for scoliosis
Gender, age, body weight and height will be recorded. The Adam’s Forward Bending Test will be performed to measure ATR as shown in Fig 3 using Scoliometer according to the standard method[5].

Ultrasound

7.5 MHz

One-off scanning

One-off scanning

X-ray of the spine would have been performed at the Student Health Service within the scoliosis screening workflow

N/A

N/A

N/A

N/A

School children of both genders recommended for radiographic assessment of spinal deformity at the School Screening Program

Patients with standing height <1 m, or >2 m

Patients with body mass index (BMI) ≥25 kg/m2

Subjects with skin diseases

Subjects with fracture or wound that affect ultrasound scanning

Subjects with ferromagnetic implants

Subjects with surgery done for the spine

Subjects with winged scapula or other irregularity of back contour that affect ultrasound scanning

Subjects who cannot stand steadily during scanning

Subjects with allergy to ultrasound gel

10

14

Both Male and Female

Interventional

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Other

N/A

2017-09-01

442

Not Yet Recruiting

Ultrasound-based Referral Status

The sensitivity and specificity of ultrasound in determining the Referral Status will be evaluated

N/A

Angle of Trunk Rotation

Evaluate if this parameter can increase the accuracy of ultrasound assessment

N/A

No

2017-07-03

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