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临床试验/NCT07070609
NCT07070609进行中(未招募)不适用

Assessment of Sagittal Spine Balance in Patients Operated on for Anterior Chest Wall Funnel Deformity

Pomeranian Medical University Szczecin1 个研究点 分布在 1 个国家目标入组 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
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
initial sagittal balance

研究概览

简要总结

Does the funnel deformity affects the sagittal balance of the spine? This question is a result of a Principal Investigator's novel observation, that in some cases restoring the correct balance reduce the distance between the retracted sternum and the spine.

The aim of the study was to assess that sagittal balance of the spine change 6 months after surgical treatment?

We assess:

  1. Deviations in sagittal balance in patients before the procedure by X-ray.
  2. Change in the distance between the sternum and the anterior part of the nearest vertebral body after virtual reproduction of the correct sagittal balance by AI.
  3. Change in the distance between the sternum and the anterior part of the nearest vertebral body 6 months after the Nuss procedure by X-ray.

详细描述

Assessment of sagittal spine balance in patients operated on for anterior chest wall funnel deformity.

Inclusion criteria:

age 10-18 idiopathic funnel chest Haller index above 3.2

Exclusion criteria:

Previous surgery within the chest and spine regions Anterior chest wall deformities caused by other disease syndromes (e.g. Marfan syndrome, Ehlers-Danlos syndrome) Haller index below 3.2

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 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •idiopathic funnel chest
  • •Haller index above 3.2

排除标准

  • •Previous surgery within the chest and spine regions
  • •Anterior chest wall deformities caused by other disease syndromes (e.g. Marfan syndrome, Ehlers-Danlos syndrome)
  • •Haller index below 3.2

结局指标

主要结局

initial sagittal balance

时间窗: 6 months

Deviations in sagittal balance in patients before the procedure

次要结局

  • initial distance(1 day)

研究者

发起方
Pomeranian Medical University Szczecin
申办方类型
Other
责任方
Sponsor

研究点 (1)

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