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临床试验/NCT04052321
NCT04052321Unknown不适用

Quantification of Chest Wall Changes After Nuss Bar Removal Utilizing Three-dimensional Optical Surface Scans

Zuyderland Medisch Centrum2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
25
试验地点
2
主要终点
Volumetric changes

研究概览

简要总结

Pectus excavatum is the most common anterior chest wall deformity that affects up to 1:400 of newborns. If an operative correction is indicated, patients are often operated via the Ravitsch or Nuss bar procedure. The latter (i.e. the Nuss bar procedure) is the most commonly performed procedure. During this procedure one or more metal bars are inserted behind the sternum to push the sternum back into its normal position. These bars remain in situ for two-to-three years before being removed. Despite the fact that the Nuss bar procedure is regarded as an effective procedure, retraction may occur after removal. A recent study has investigated this phenomenon, utilizing three-dimensional (3D) optical surface scans acquired before and after Nuss bar removal. The authors found statistically significant changes to occur in chest wall dimensions directly after, as well as between 2 and 8 weeks after Nuss bar explantation, in comparison to the situation just prior to bar removal. They, moreover, found the time the bar was in situ to be predictive for retraction. However, the authors also stressed that further studies are needed to reinforce their preliminary findings and perform long-term assessments. Subsequently, a similar study with long-term assessments will be conducted.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients that received 1 or more Nuss bar(s) to treat pectus excavatum and is/are scheduled to be removed due to the end of treatment.

排除标准

  • Patients in which the Nuss bar(s) or its stabilizers are or have been dislocated.
  • Patients that received a second operation to treat any complications regarding the initial Nuss bar implantation.
  • Patients with proven connective tissue diseases (e.g. Marfan's syndrome).
  • Patients with a diagnosis of epilepsy (as the 3D scanner utilizes flashing light to acquire the torso topography)
  • Patients that are not fit to remain in a standing position with their arms above shoulder level for a maximum of 60 seconds.

结局指标

主要结局

Volumetric changes

时间窗: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months

The volumetric chest wall changes

Mean change in distance

时间窗: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months

The mean distance of thoracic wall changes

Maximum change in distance

时间窗: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months

The maximum distance of thoracic wall changes

次要结局

  • Predictors of chest wall changes(Changes in volume, mean and maximum distance from baseline to 12 months)

研究者

发起方
Zuyderland Medisch Centrum
申办方类型
Other
责任方
Sponsor

研究点 (2)

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