Nautilus: Dynamic Craniotomy; New Surgical Technique and Preliminary Results
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Nautilus: dynamic craniotomy; new surgical technique and preliminary results
研究概览
简要总结
Being the craniostenoses sutural basically a disease, the fact that the brain being trapped in an enclosure that does not have complacency required to accompany their growth constitutes the challenge of treatment, which aims to restore the complacency of the suture and correct the stenotic compensatory cranial deformity.
This paper proposes the combination of a helicoid osteotomy distraction osteogenesis provided by the use of springs distracting.
详细描述
As demonstrated by some authors, the curved shape of the helix fits perfectly the remodeling of a curved surface as well as the skullcap. If you do not receive fixation, however, trace the helicoid of the bone osteotomy can turn on a spring that can expand or contract depending on the direction of the force that is received. This form of osteotomy was therefore chosen by the authors to induce bone compliance areas of secondary defect that should expand or compress indirectly during the process of dynamic remodeling of primary defect with springs.
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
- 6 Months 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 6 months to 13 years
排除标准
- •absence of clinical conditions for the surgical treatment
结局指标
主要结局
Nautilus: dynamic craniotomy; new surgical technique and preliminary results
时间窗: Up to 3 years
This study proposes to analyze the cranial remodeling achieved through the use of a dynamic craniotomy, without detachment of the dura mater in cranial deformities caused by craniosynostosis.
cranial remodeling
时间窗: Up to 3 years
Quantify the results of cranial remodeling by osteotomy helicoid-shaped Nautilus by clinical and CT in 6 months after the procedure, by 3 surgeons at different times - The skull shape, postoperatively, will be assessed independently by four surgeons, who will use the following scale results: insufficient when there was no attenuation of preoperative deformity, partial, when the correction happened, but was not able to capture all the characteristics of the deformity; appropriate, when there was complete remission of cranial deformity.
次要结局
未报告次要终点