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临床试验/NCT03298256
NCT03298256已完成不适用

Three-dimensional Effects of Bracing in Adolescent Idiopathic Scoliosis

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
1
主要终点
Compare change in three dimensional (3D) effect of bracing on the adolescent idiopathic scoliosis (AIS) using the EOS Imaging System

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
10 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Compare change in three dimensional (3D) effect of bracing on the adolescent idiopathic scoliosis (AIS) using the EOS Imaging System

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Kenny Kwan

Clinical Assistant Professor

The University of Hong Kong

研究点 (1)

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