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临床试验/NCT04527406
NCT04527406撤回不适用

Early Hemivertebra Resection of Congenital Hemivertebra in Very Young Children: A Randomized Clinical Study

Children's Hospital of Fudan University0 个研究点目标入组 60 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
60
主要终点
Duration of surgery

研究概览

简要总结

Early treatment of congenital hemivertebrae is very important. The investigators design this study to figure out how early hemivertebrae resection be apply to children. Children aged 3-5 years old diagnosed as congenital hemivertebrae will be randomly divided into early operation group and control group. The early operation group will undergo posterior hemivertebra resection. The control group received brace plaster fixation to reduce the progression of scoliosis, and then will undergo operation after 5 years old. Primary Outcome Measure is the length of spine surgery.

详细描述

Early diagnosis and early effective treatment of congenital hemivertebrae can correct the deformities.Therefore, traditionally, children with a clear diagnosis should be fixed with a brace to delay the aggravation of scoliosis and then undergo surgery after 5 years of age. The design of this study is to conduct a single-center randomized controlled study. Children aged 3-5 years old diagnosed as congenital hemivertebrae will be randomly divided into the early operation group and the control group. The early operation group will undergo posterior hemivertebra resection. The control group received brace plaster fixation to reduce the progression of scoliosis, and posterior scoliosis correction will be performed after the age was over 5 years old. The primary outcome measures are the length of spine surgery for the two groups of children. The secondary outcome measures are change of scoliosis cobb angle, by comparing preoperative and postoperative cobb angle changes. It is expected that the early treatment group will shorten the length of surgery due to the smaller degree of scoliosis. Our research is expected to broaden the age-adaptation of classic spinal surgery in the field of pediatric spine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes Assessor conduct independent statistical analysis and evaluation

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Single-segment thoracic or lumbar hemivertebrae scoliosis diagnosed by X-ray and CT.

排除标准

  • Diagnosed with syndrome of scoliosis, osteochondrodysplasia, multi-segment hemivertebrae deformity, cervical hemivertebrae deformity

结局指标

主要结局

Duration of surgery

时间窗: The operation time: from the beginning of the surgical skinning to the end of the surgical suture

The length of posterior hemivertebra resection operation time, acquired in the operation record from hospital

次要结局

  • change of scoliosis cobb angle(intraoperative)

研究者

申办方类型
Other
责任方
Sponsor

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