NCT05108948招募中不适用
Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity : Observational Study (COFTASD)
Elsan1 个研究点 分布在 1 个国家目标入组 866 人开始时间: 2021年10月23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 improved oswestry disability score
研究概览
简要总结
The objective of this study is to find the predictive factors of improvement of the quality of life of operated patients from spinal deformity.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years-old
- •Diagnosis of Adult Spinal Deformity with any of the deformity characteristics following:
- •Scoliosis with a Cobb angle ≥ 20 °
- •Vertical sagittal axis (SVA) ≥ 5 cm
- •Pelvic tilt ≥25 °,
- •Thoracic kyphosis with a Cobb angle ≥ 60 °
- •Eligible for surgery
- •Having given their participation agreement
- •Affiliate or beneficiary of a social security scheme
排除标准
- •Age under 18 years-old
- •Patient unlikely to comply with follow-up
- •Patient with long-term complete paraplegia
- •Patient unable to understand and answer questionnaires in due to language difficulties or cognitive impairment
- •Pregnant or breastfeeding woman
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
结局指标
主要结局
Factors associated with improved oswestry disability score
时间窗: 15 years
The factors associated with an improvement in the ODI score, 1 year after surgery, will be sought among the initial characteristics (before surgery) and within 3 months after surgery. An improvement in ODI score is defined as a decrease in score at 1 year of at least 10 points from baseline.
次要结局
未报告次要终点
研究者
研究点 (1)
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