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临床试验/NCT05424419
NCT05424419已完成不适用

Retrospektive Analyse Der Konservativen Skoliosetherapie - Doppelkorsettversorgung Mittels Tag- Und Nachtorthese Versus Ganztagesorthese

Technische Universität Dresden0 个研究点目标入组 115 人开始时间: 1997年1月2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
115
主要终点
primary correction

研究概览

简要总结

Bracing is an accepted standard therapy for idiopathic scoliosis at Cobb angle ranges between 25° and 45°. However, it is unclear, if a specifically tailored regimen of daytime and nighttime braces (=double brace) yields superior results compared to the standard treatment (single brace for day and night). These two treatment regimens were investigated in the study.

详细描述

One-hundred-fifteen patients with adolescent idiopathic scoliosis (AIS) were assessed before initiation of bracing treatment and at the final follow-up 2 years after deposition of the brace. They were divided into two groups: double-brace group and single-brace group. Each patient underwent clinical and radiological examinations and Cobb angles were measured.

研究设计

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

入排标准

年龄范围
10 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age between 10 and 15 years (y)
  • Risser's sign of 0-2
  • Cobb curvature angle of 25-40°
  • no previous treatment
  • compliance (at least 23 h wearing time)

排除标准

  • non-idiopathic scoliosis
  • Cobb curvature angle >40°
  • <10 years and >15 years for initial treatment

结局指标

主要结局

primary correction

时间窗: At study inclusion with initiation of brace therapy

Primary correction (%) of brace therapy (Cobb angle measurement)

次要结局

  • Cobb angle reduction(2 years after deposition of the brace)

研究者

申办方类型
Other
责任方
Sponsor

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