Prognosis Factors for the Treatment of Pectus Carinatum With a Dynamic Compression System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Decrease of the deformation of more than 50% (measured in mm) after 6 months of treatment
研究概览
简要总结
Pectus carinatum is a deformation of the thoracic wall causing an aesthetic prejudice. Since 2011, our team uses a dynamic compression system to treat this deformation. It is a harness that the patient wears all day long for an average duration of 1 year, and that remodels the chest by exerting a moderate pressure on it. The local cohort is one of the largest in the world. The few previous publications have shown the validity of this method, but the prognosis factors for success of this innovative treatment are not yet identified.
详细描述
The principal insvestigator hypothesizes that the success or failure of the treatment depends on several parameters assessable before treatment, such as the patient's age, gender, initial correction pressure, symmetry or not of the deformation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who received proper information about the study.
- •Patient with clinically diagnosed pectus carinatum.
- •Treated at Saint-Etienne University Hospital using a dynamic compression system.
- •Between October 2011 and January 2020 for the retrospective part, then between January 2020 and January 2022 for the validation cohort.
- •With more than 6 months of follow-up since the beginning of the treatment.
排除标准
- 未提供
结局指标
主要结局
Decrease of the deformation of more than 50% (measured in mm) after 6 months of treatment
时间窗: After 6 months of treatment
Dynamic compression system
次要结局
- Failure of treatment assessed by the patient, ie if the patients considers the treatment to have failed, if he choose to underwent surgery afterwards, or if he considered the pectus carinatum to have relapsed(After the end of treatment (6 months to 2 years))