NCT05145725招募中不适用
Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis: Observational Study
Elsan1 个研究点 分布在 1 个国家目标入组 866 人开始时间: 2021年3月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 866
- 试验地点
- 1
- 主要终点
- Factors associated with an improvement in the SRS-22r score
研究概览
简要总结
The study population concerns adolescent patients with idiopathic scoliosis which requires surgical management and who have a longer waiting period of 6 months.
The aim of this study is to research the predictive factors of an improvement in the quality of life of adolescents who have had surgery.
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
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between 12 and 20 years old
- •Scoliosis in adolescents for whom surgery has been proposed based on radiological criteria (Cobb angle> 25 ° for thoracolumbar and lumbar scoliosis,> 35 ° for thoracic scoliosis and> 40 ° for double major scoliosis)
- •Patient affiliated or beneficiary of a social security scheme or attached to a beneficiary of a social security scheme
- •Patient and legal representative having been informed and not opposing this research
排除标准
- •Patient over 20 years old
- •Non-surgical scoliosis
- •Refusal to participate in the study by the child or parents
结局指标
主要结局
Factors associated with an improvement in the SRS-22r score
时间窗: 1 year
Factors associated with an improvement in the SRS-22r score, 1 year after surgery, will be sought among the initial characteristics (before surgery) and within 3 months after surgery. An improvement in SRS-22r score is defined as an increase in the total score at 1 year of at least 10% from value.
次要结局
未报告次要终点
研究者
研究点 (1)
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