Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00570

2 Trial Registration Date

2017-11-21

i Registration Status

Prospective

3 Secondary IDs

CREC Ref: 2016.134

4 Source(s) of Funding

N/A

5 Primary Sponsor

Sai-wing SIN

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Sai-wing SIN

ii Address

Department of Prosthetics and Orthotics, Prince of Wales Hospital, CUHK, Shatin

iii Phone

+852235053930

iv Email

sinsw@ha.org.hk

v Affiliation

Department of Prosthetics and Orthotics, PWH

vi Country

Hong Kong

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

i Name

Sai-wing SIN

ii Address

Department of Prosthetics and Orthotics, Prince of Wales Hospital, CUHK, Shatin

iii Phone

+852235053930

iv Email

sinsw@ha.org.hk

v Affiliation

Prosthetics and Orthotics Department, Prince of Wales Hospital

vi Country

Hong Kong, China

9 Official Scientific Title of the Study

Design and Evaluation of Orthotic Treatment for Patients with Adolescent Idiopathic Scoliosis using a Purpose-design Assessment Frame and 3-Dimensional Clinical Ultrasound Analysis

10 Public Title

Design and Evaluation of Orthotic Treatment for Patients with Adolescent Idiopathic Scoliosis using a Purpose-design Assessment Frame and 3-Dimensional Clinical Ultrasound Analysis

i Public Title in Chinese 研究名稱

三維超聲波檢查系統運用於脊柱側彎評估和改善脊柱矯形器的設計

11 Short Title (Optional)

Using ultrasound and assessment frame to design and evaluate the spinal orthoses for scoliotic patients

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?

2017-04-28

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.134

14 Medical Condition Being Studied

Scoliosis deformity

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

To control the progression of moderate curves in patients with adolescent idiopathic scoliosis (AIS), spinal orthoses have been prescribed for decades.The procedure of orthosis design initiates with the casting (scanning) of the patient's trunk as a reference for the fabrication of orthosis. Traditionally, the experiential judgment of orthotist and available pre-orthosis radiographs play the fundamental role in the procedure to modify the captured trunk model. This subjective method necessitates the development of an objective real-time method of orthosis casting while the correction of spinal curvature during the casting (scanning) is documented to achieve the intended correction before the fabrication of orthosis. This prospective randomized study evaluates the effectiveness of an innovative design method with 3-D ultrasound and assessment frame in orthotic treatment of scoliotic patients to assess the potential superiority of this modified casting procedure over the conventional casting method. The brace wearing will continue according to the protocols of SRS/SOSORT normally till complete skeletal maturity.

iii Dosage form of the intervention

Not applicable

iv Dosage of the intervention

Not applicable

v Duration of the intervention

1 hour in assessment/casting session and 15 minutes during the first in-brace assessment session

vi Frequency of the intervention

Once during the casting and then once during the first in-brace assessment

16 Comparative Treatments

i Description/ name of comparative treatments

The control group will receive the conventional casting procedure for the orthosis design of adolescent idiopathic scoliosis.

ii Dosage form of the comparative treatments

Not applicable

iii Dosage of the comparative treatments

Not applicable

iv Duration of the comparative treatments

Both groups will wear the brace according to the protocols introduced by SRS/SOSORT

v Frequency of the comparative treatments

No difference from usual conventional treatment in terms of brace dosage

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Adolescent idiopathic patients

Risser's Sign 0-2

Primary curve magnitude 25 to 40 degrees

Females either pre-menarche or less than one year post-menacarche

ii Exclusion Criteria

Physical or mental disability preventing patients from complying with the bracing protocol

Curve types of high thoracic due to the limitation of the apparatus to apply the force in that level

iii Age Minimum

10

iv Age Maximum

17

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Randomized control trial

ii Nature of control

Not Applicable

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

1

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-11-27

21 Target Sample Size

40

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

In-brace correction

ii The metric or method of measurement used

≥30% Correction in 3D ultrasound assessment

iii The timepoint(s) of primary interest

Before treatment-assessment session (0 week), fitting session , first in-brace X-ray session (4-6 weeks)

24 Secondary Outcome

i The Name of the outcome

Changes in Cobb angle

ii The metric or method of measurement used

≤ 5° with and without brace assessed in radiographs

iii The timepoint(s) of primary interest

Before treatment-assessment session (0 week), first in-brace X-ray session (4-6 weeks)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-12-15

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2017-11-21