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临床试验/NCT04945343
NCT04945343Unknown不适用

Long-Term Follow-Up Of Surgical Management Of Early Onset Scoliosis Using Growing Rods

Assiut University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Percentage of improvement in the functional outcome of these patients using the EOSQ-24, Arabic Version)

研究概览

简要总结

The aim of this work is to evaluate the long-term outcome of the graduates (those who completed the gradual lengthening procedures), to better understand the full scope and natural course of Growing Rods treatment for EOS and to have a glimpse of what happens to the graduates.

详细描述

The management of progressive early onset scoliosis (EOS) is challenging. The natural history can be severe deformity, restrictive lung disease, and early mortality . In the past, the standard of care for these children was early definitive spinal fusion and instrumentation. The belief was that a short and straight spine was superior to a long and deformed spine despite the negative effects of a short trunk. The principles of EOS treatment have changed with the appreciation that early fusion of the thoracic spine limits the growth of the spine and lungs, and eventually leads to respiratory failure and increased mortality. Furthermore, the cosmetic disfigurement from the disproportionate Trunk-Limb length is always not acceptable by the patients.

The surgical treatment strategy for EOS has evolved significantly with the use of modern growth friendly implants, of these, Growing Rods(GR), first described by Moe and colleagues, attempt to allow the growth of the spine and thorax while controlling curve progression to preserve normal lung volume. Since then, several modifications and developments have been made and introduced worldwide.

Evaluation of the mid to long-term follow up has seldom been reported in the literature. In Assiut university hospital the investigators operated a fair amount of children with EOS using growing rods starting 2009, with favourable short term results. The long-term outcome of the graduates (those who completed the gradual lengthening procedures), remains yet to be evaluated and reported.

Research Methods and techniques:

Type of the study: case series

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Patients whose parents or guardians are not willing to participate in the study.

结局指标

主要结局

Percentage of improvement in the functional outcome of these patients using the EOSQ-24, Arabic Version)

时间窗: Through study completion, an average of 2 years.

A score that measures the wider dimensions of outcomes involving the quality of life of patients and caregivers post-treatment.

次要结局

  • Patient satisfaction (Likert scale)(Through study completion, an average of 2 years.)
  • The degree of correction of the scoliosis and kyphosis.(Through study completion, an average of 2 years.)
  • Trunk Height Gain (T1-S1 height).(Through study completion, an average of 2 years.)
  • sagittal and coronal balance(Through study completion, an average of 2 years.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Hatem Ahmed Mohammed

Assistant lecturer

Assiut University

研究点 (2)

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