Demonstrator in Oral and Maxillofacial Surgery Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Linear deviation of anatomical landmarks between postoperative outcome and preoperative virtual plan
研究概览
简要总结
Stock reconstruction plates have been used for decades and represent a tried-and-true alternative to custom plating. Stock plates are readily available, are cost effective, and can be accurately bent before surgery, particularly when using stereolithographic models. Unfortunately, the use of stock plates typically precludes the utilization of predictive holes; this can make inset more difficult as the plates do not precisely match the native mandibular contour. Previous descriptions of fabricating predictive holes with stock plates have been inaccurate and inefficient.
We aim with conducting this research to improve on the ability of pre-bent stock plates of reproducing the VSP in the operating theater allowing accurate native mandible fixation, accurate fibular segments harvest and accurate inset of the reconstruction in lieu of using the expensive alternative of PSI, thus expanding the use of VSP in mandibular reconstruction in resource limited institutions.
详细描述
Aim of the study:
The aim of the study is to evaluate the accuracy of mandibular reconstruction with free fibula flaps utilizing a novel design of resection and cutting guides based on reverse engineering stock plates into the VSP workflow.
Hypothesis:
The null hypothesis is that there is no significant difference between the postoperatively reconstructed mandible with free fibula flap and the virtually reconstructed mandible preoperatively
PICO:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with segmental mandibular defects who are planned for free fibula flap reconstruction
- •Patients presenting either for immediate reconstruction following resection of tumor or presenting for secondary reconstruction
排除标准
- •Known allergies or sensitivities to materials such as titanium or acrylic or resin.
- •Inability to return for follow up visits.
结局指标
主要结局
Linear deviation of anatomical landmarks between postoperative outcome and preoperative virtual plan
时间窗: immediately on the post op CT scans
Continuous numerical (mm)
次要结局
未报告次要终点
研究者
Mohamed Ghorab
Demonstrator in Oral and Maxillofacial surgery department
Cairo University
