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Trial Detail

CUHK_CCRB00570

2017-11-21

Prospective

CREC Ref: 2016.134

N/A

Sai-wing SIN

N/A

Not Applicable

Sai-wing SIN

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

+852235053930

sinsw@ha.org.hk

Department of Prosthetics and Orthotics, PWH

Hong Kong

Sai-wing SIN

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

+852235053930

sinsw@ha.org.hk

Prosthetics and Orthotics Department, Prince of Wales Hospital

Hong Kong, China

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

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

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

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

Hong Kong

Yes

2017-04-28

Joint CUHK-NTEC Clinical Research Ethics Committee

2016.134

Scoliosis deformity

Procedure

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.

Not applicable

Not applicable

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

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

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

Not applicable

Not applicable

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

No difference from usual conventional treatment in terms of brace dosage

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

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

10

17

Both Male and Female

Interventional

Randomized

Randomized control trial

Not Applicable

Single-blind

Investigator/research team

Parallel

1

2017-11-27

40

Not Yet Recruiting

In-brace correction

≥30% Correction in 3D ultrasound assessment

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

Changes in Cobb angle

≤ 5° with and without brace assessed in radiographs

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

No

2017-12-15

ChiCTR-IOR-17013514

2017-11-21

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