NCT03298256

Three-dimensional Effects of Bracing in Adolescent Idiopathic Scoliosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 53 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 10 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adolescent Idiopathic Scoliosis

Interventions

Type	Name	Description
RADIATION	EOS X-rays	Full length, orthogonal anteroposterior and lateral X-rays will be taken simultaneously in a standardised standing position, with arms folded anteriorly in 45 degrees . All radiographs will include C7 proximally and the femoral heads distally. 3D reconstruction of the spine can be performed. X-rays will be repeated 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. Coronal, sagittal and axial parameters will be calculated from the reconstruction. 3D vertebral wedging will be calculated in the posterofrontal, sagittal and diagonal planes at the apex, 3 superior and 3 inferior vertebrae, as described by Scherrer et al. Changes in the pre- and post-bracing and follow-up parameters can be calculated.

Timeline

• Start date: 2015-11-01
• Primary completion: 2019-05-31
• Completion: 2021-12-31
• First posted: 2017-10-02
• Last updated: 2022-05-24

Locations

1 site across 1 country: Hong Kong