Centre For Clinical Research And Biostatistics (CCRB)

Back

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00552

2 Trial Registration Date

2017-04-13

i Registration Status

Prospective

3 Secondary IDs

ScoE_Protocol_V01

4 Source(s) of Funding

Health and Medical Research Fund

5 Primary Sponsor

Health and Medical Research Fund

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Lyn Wong

ii Address

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

iii Phone

26323309

iv Email

lynwong@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Lam Tsz Ping

ii Address

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

iii Phone

26323309

iv Email

b132720@mailserv.cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

ScoE

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-12-06

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.658

14 Medical Condition Being Studied

Scoliosis

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

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].

iii Dosage form of the intervention

Ultrasound

iv Dosage of the intervention

7.5 MHz

v Duration of the intervention

One-off scanning

vi Frequency of the intervention

One-off scanning

16 Comparative Treatments

i Description/ name of comparative treatments

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

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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

ii Exclusion Criteria

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

iii Age Minimum

10

iv Age Maximum

14

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

N/A

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-09-01

21 Target Sample Size

442

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Ultrasound-based Referral Status

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

N/A

24 Secondary Outcome

i The Name of the outcome

Angle of Trunk Rotation

ii The metric or method of measurement used

Evaluate if this parameter can increase the accuracy of ultrasound assessment

iii The timepoint(s) of primary interest

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-07-03

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

Back

Trial History Detail on 2017-04-13