Three-dimensional Effects of Bracing in Adolescent Idiopathic Scoliosis

Completed

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: Radiation: EOS X-rays

• Registration Number: NCT03298256
• Lead Sponsor: The University of Hong Kong

Brief Summary

This study intends to investigate the three dimensional (3D) effect of bracing on the adolescent idiopathic scoliosis (AIS). In particular, it will look at the relationship between frontal deformity correction and changes in the sagittal profile and apical vertebral rotation (AVR) during bracing. The investigators hypothesise that if the thoracic frontal deformity can be controlled with bracing, there will be spontaneous correction of the sagittal plane and rotation deformity through coupling.

Detailed Description

Scoliosis is a 3D deformity of the spine with curvatures occurring in three planes.

The efficacy of bracing in correcting the frontal deformity is now well-accepted after the Bracing in Adolescent Idiopathic Scoliosis Trial (BRAIST). Restoration of the sagittal alignment is one of the fundamental goals in scoliosis treatment. The investigators have previously demonstrated on fulcrum bending radiographs that there is coupling between the frontal deformity, thoracic kyphosis and apical vertebral derotation. The investigators' findings suggest that there may be natural coupling of the frontal and sagittal deformities towards "self-normalisation" during correction of the curves. The effect of bracing on the sagittal alignment and 3D deformity in scoliosis is currently not well-understood. If there is a tendency for the natural curve behaviour to return towards a more normal sagittal alignment, then bracing may exert a similar effect on the 3D profile. Understanding how the 3D deformity is affected by bracing allows further insight into curve progression and brace effectiveness.

Few studies in the literature have addressed the sagittal profile and 3D correction by bracing. Of those, the findings were based on vertebral reconstructions obtained from CT-scan, finite element analysis modelling, or studying the changes in the rib cage rotation. However, the investigators propose to measure the 3D profile using the modern EOS ® system, which allows biplanar radiography and 3D calculations and a more accurate measurement of vertebral wedging.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-11-01
• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-09-28
• Study First Posted: 2017-10-02
• Primary Completion: 2019-05-31
• Study Completion: 2021-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-21
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

-Diagnosis of Lenke type 1 AIS who fulfil the normal criteria for bracing

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Exclusion Criteria

• if the aetiology of the scoliosis is not idiopathic
• does not belong to Lenke type 1
• previous treatment with a brace
• severe presentation requiring surgical intervention
• unavailable for regular follow-up
• parents are unable to give informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lenke type 1 AIS	EOS X-rays	Patients will be given a new prescription for a custom made Boston type thoracic-lumbo- sacral-orthosis (TLSO) braces. All patients will undergo low dose biplanar X-rays using the EOS ® machine system.

Primary Outcome Measures

Name	Time	Method
Compare change in three dimensional (3D) effect of bracing on the adolescent idiopathic scoliosis (AIS) using the EOS Imaging System	Follow-up to 3 years	To compare change in full length, orthogonal anteroposterior and lateral X-rays in a standardised standing position after the brace is applied, and at intervals of no fewer than 6 months until the brace is weaned off, or if surgical intervention is required

Secondary Outcome Measures

Name	Time	Method
Measure health-related quality of life outcome by the 22-item Scoliosis Research Society questionnaire (SRS-22) of patients with adolescent idiopathic scoliosis (AIS)	Follow-up to 3 years	To compare change in the health-related quality of life outcome of patients with adolescent idiopathic scoliosis (AIS) by the 22-item Scoliosis Research Society questionnaire (SRS-22), with the minimum score of 22 to the maximum score of 110. Higher score means better health outcome

Trial Locations

Locations (1)

Duchess of Kent Children's Hospital; 🇭🇰 Hong Kong, Hong Kong