Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 26
- 主要终点
- Immediate effectiveness of surgery: Evolution of Cobb angle
研究概览
简要总结
The treatment of child's vertebral malformations has evolved a lot including the realization of surgical vertebral resections. The surgical techniques used are multiple, require heavy surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to 20% in some series, risk of non-consolidation, insufficient correction). These surgical techniques deserve an evaluation of the early complications and the skeletal maturity of these children (maintenance of the surgical correction, evolution of the associated curvatures).
详细描述
The treatment of child's vertebral malformations has evolved a lot including the realization of surgical vertebral resections. The surgical techniques used are multiple, require heavy surgery, one or more approaches and surgical time, transfusions, a neurological risk (up to 20% in some series, risk of non-consolidation, insufficient correction). These surgical techniques deserve an evaluation of the early complications and the skeletal maturity of these children (maintenance of the surgical correction, evolution of the associated curvatures).
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
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child from 3 to 10 years old
- •with a vertebral malformation requiring surgery for hemivertebras
排除标准
- •Child previously operated on the spine
- •Different procedure of a surgical resection of vertebral malformation
- •Absence of medical follow-up
- •Parents refusal concerning data storage
研究组 & 干预措施
Surgical treatment of hemivertebra
cohort of children with a vertebral malformation treated by surgical resection
干预措施: Surgical resection (Procedure)
结局指标
主要结局
Immediate effectiveness of surgery: Evolution of Cobb angle
时间窗: From baseline to 6 months after surgery
Effectiveness of immediate correction : spinal deformities measured by the Cobb angle on radios face and profile
Late persistence of complications
时间窗: From 6 months after surgery to 15 years
Persistent complications will be collected through clinical examination at follow-up visits.
Appearances of complications
时间窗: From baseline to 6 months after surgery
Appearances of complications (neurological, vascular, non consolidation) at 6 months. These complications will be gathered from hospitalization reports.
次要结局
- Long-term effectiveness of surgery: Evolution of Cobb angle(From 6 months after surgery to 15 years)