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临床试验/NCT04633031
NCT04633031撤回不适用

The Effect of Bracing on Sagittal Balance in Scoliosis, Are we Doing the Right Thing?

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Delordosing effect of TLSO brace

研究概览

简要总结

The goal of the study is to analyze the influence of bracing on sagittal balance in scoliosis. In special we want to observe if there is a difference between two types of TLSO-brace, namely boston and cheneau.

Retrospective analyses of Full Spine X-rays of patients who underwent bracing-therapy in the context of scoliosis.

Different spinopelvic parameters will be analyzed: pelvic incidence, pelvic tilt, sacral slope, lumbar lordosis, spinopelvic angle, spinosacral angle, thoracal kyphosis.

Four different X-rays will be reviewed for these parameters:

  1. Profile before bracing therapy
  2. Profile after initiation of bracing therapy
  3. Profile immediately after termination of bracing therapy
  4. Profile more than 3 months after termination of brace

It concerns patients with idiopathic scoliosis (exclusion of congenital scoliosis, neuromuscular scoliosis and associated spondylolisthesis).

Goal of the study is to check if treatment with TLSO-brace has a delordosing effect on sagittal balance (decrease of lumbar lordosis).

The zero-hypothesis: TLSO causes no decrease in lumbar lordosis.

Secondary goal is to compare the effect of the BOSTON TSLO-brace and otherwise the CHENEAU TLSO-brace on spinopelvic parameters and lumbar lordosis in special.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • late onset idiopathic scoliosis
  • non-operative indication

排除标准

  • early onset idiopathic scoliosis
  • neuromuscular scoliosis
  • congenital scoliosis
  • associated spondylolisthesis
  • operative indication

结局指标

主要结局

Delordosing effect of TLSO brace

时间窗: 3 years

次要结局

  • Difference between Boston and Cheneau brace concerning delordosing effect(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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