Assessment and Follow-up of Surgical Treatment of Hemivertebra in Children

University Hospital, Tours26 个研究点分布在 1 个国家目标入组 150 人2019年2月4日

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).

注册库

clinicaltrials.gov

开始日期

2019年2月4日

结束日期

2039年2月1日

最后更新

前天

研究类型

Observational

性别

All

研究者

发起方

University Hospital, Tours

责任方

Sponsor

入排标准

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

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.