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临床试验/NCT03087734
NCT03087734已完成不适用

Evaluation of a New Model of Metallic Bar and Stabilizer for Use in the Minimally Invasive Repair of Pectus Excavatum

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Grade of metallic bar dislodgment measured through Rx images

研究概览

简要总结

Pectus excavatum (PE) is the most common deformity of the chest wall, occurring in approximately 1/1000 people. Currently, surgical treatment by minimally invasive technique is consolidating as preferred technique for the treatment of this condition. In this technique a metal bar is inserted in retrosternal position, pushing the sternum without the necessity of resecting the condral cartilages. Despite the advantages obtained with this technique, it is not without complications and the displacement of the bar is one of the most important. In order to minimize this problem we developed a new model of stabilizers, as well as all necessary instruments for performing minimally invasive surgery. The aim of this study is to compare two surgical groups, one making use of the new oblique stabilizer compared to the conventional perpendicular stabilizer to determine which one has less displacement. Furthermore, this study also aims to assess the full range of instruments developed by a national company, to carry out this type of surgery, which has cost compatible with our economic reality, and that can be accessible to our Public Health patients.

详细描述

Introduction Pectus excavatum (PE) is presented as a sunken sternum in the midline and these chest deformities are not uncommon, occurring in approximately 1/1000.

It is commonly accepted that the abnormal growth of condral cartilage results in displacement of the sternum. Most patients and their parents seek medical advice for psychosocial concerns, particularly related to the cosmetic aspects and the consequent aversion to sports or public exposure. Physiological tests are often normal, but both the cardiac index and pulmonary function may be affected.

Surgical treatment of pectus excavatum Nuss broke the paradigm in PE surgery with the publication of their results using a technique called minimally invasive. This technique involves lateral incisions in the chest and the placement of one or two temporary steel bars, which are shaped during surgery, specifically for each patient. These bars are placed in retrosternal position and the sternum is elevated without the need of cartilage resection.

This surgical technique, in addition to the bars and stabilizers, needs a set of instruments that are used in the customization of the bar for each patient and, after three years, the withdrawal of the bar at the end of the treatment.

Another problem refers to the displacement of the metallic bars that are positioned under the sternum and that are held in position by placing stabilizers, one at each lateral end of the bar. These stabilizers, which are perpendicular to the bar, has the function to expand its area of contact with the chest wall in order to prevent it from moving from its position.

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
None

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pectus excavatum patients

排除标准

  • Presence of complex congenital anomalies;
  • Retardation neurodevelopment;
  • Congenital heart disease;
  • Chronic Immunosuppression.

结局指标

主要结局

Grade of metallic bar dislodgment measured through Rx images

时间窗: One year

The grade of metallic bar dislodgment will be measured through the comparison of the Rx taken in patient follow up in terms of: a) bar flipping; b) lateral sliding and c) hinge-point disruption

次要结局

未报告次要终点

研究者

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

Miguel L. Tedde

Principal Investigator

University of Sao Paulo

研究点 (1)

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