Impact Des inégalités Socio-économiques et Territoriales Sur la qualité de Vie pré et Post opératoire Des Scolioses Idiopathiques Prisent en Charge en Milieu pédiatrique
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change from baseline quality of life (SRS-22) at one year after surgery depending on the socio-economic level and remoteness.
研究概览
简要总结
The incidence of idiopathic scoliosis is 3% or approximatively 300,000 new cases per year in France. It is estimated that between 0.1 and 0.3% of patients will eventually require surgical management, between 500 and 1000 scoliosis are operated per year in France. To our knowledge, the impact of socio-economic and territorial inequalities on the quality of life before and after surgery of idiopathic scoliosis has not been studied previously.
Main objective:
-Assess the impact of socio-economic and territorial inequalities on the pre- and post-operative quality of life at 1 year after surgical idiopathic scoliosis management, in a French pediatric surgery multicenter cohort.
Secondary objective:
- Assess the impact of socio-economic and territorial inequalities on the quality of life pre and postoperative at 3 months after surgery on a French multicenter cohort.
- To assess the impact of severity and type of scoliosis on pre- and post-operative quality of life at 3 months and 1 year after surgery on a French multicenter cohort.
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 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Operated by posterior vertebral arthrodesis
- •Opereted in pediatric surgery center
- •Idiopathic scoliosis treated by surgery
排除标准
- •Refusal to participate
- •People unable to read or speak French (the questionnaire being in French)
- •Non-idiopathic scoliosis
结局指标
主要结局
Change from baseline quality of life (SRS-22) at one year after surgery depending on the socio-economic level and remoteness.
时间窗: At 1 years after surgery. Baseline questionnaire will be assessed just before the surgery
We will use the SRS-22 questionnaire, a specific questionnaire validated in French to assess the quality of life of patients with scoliosis. The questionnaire coverts different part of socio-economic levels including the salary, the educational level, the type of social security coverage, the parents' family situation (single parent, two-parent, blended couple) and the number of people and pieces in the habitation. The remoteness will be evaluated by the distance between the medical referent center and the habitation.
次要结局
- Clinical data: age(at the surgery)
- Radiological data: angulation parameters(at the time of surgery and at one year fater surgery)
- Clinical data: previous treatments(at the surgery)
- Radiological data : type of scoliosis(at the time of surgery and at one year fater surgery)
- Clinical data: weight(at the surgery)
- Clinical data: family history(at the surgery)
- Surgery data(during the firts year after the surgery)
研究者
Nathan DOLET
MD
University Hospital, Caen