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临床试验/NCT05672056
NCT05672056招募中不适用

Demonstrator in Oral and Maxillofacial Surgery Department

Cairo University2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年5月最近更新:
适应症

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

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

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

Mohamed Ghorab

Demonstrator in Oral and Maxillofacial surgery department

Cairo University

研究点 (2)

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