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临床试验/NCT05603949
NCT05603949招募中不适用

Development of Three-dimensional Deep Learning for Automatic Design of Skull Implants

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2023年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
6
试验地点
1
主要终点
Number of patients where there is no need to augment/fill clefts between the Patient Specific Implant (PSI) and patient´s bone

研究概览

简要总结

This project aims to develop an effective deep learning system to generate numerical implant geometry based on 3D defective skull models from CT scans. This technique is beneficial for the design of implants to repair skull defects above the Frankfort horizontal plane.

详细描述

Designing a personalized implant to restore the protective and aesthetic functions of the patient's skull is challenging. The skull defects may be caused by trauma, congenital malformation, infection, and iatrogenic treatments such as decompressive craniectomy, plastic surgery, and tumor resection. The project aims to develop a deep learning system with 3D shape reconstruction capabilities. The system will meet the requirement of designing high-resolution 3D implant numerical models efficiently.

A collection of skull images were used for training the deep learning system. Defective models in the datasets were created by numerically masking areas of intact 3D skull models. The final implant design should be verified by neurosurgeons using 3D printed models.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for cranioplasty
  • Informed consent

排除标准

  • (1)No informed consent

结局指标

主要结局

Number of patients where there is no need to augment/fill clefts between the Patient Specific Implant (PSI) and patient´s bone

时间窗: 6 weeks after surgery by standardised questionnaire

Number of patients where there is no need to augment/fill clefts between the Patient Specific Implant (PSI) and patient´s bone

Number of patients where there is no need to adapt the Patient Specific Implant (PSI) edges

时间窗: 6 weeks after surgery by standardised questionnaire

Number of patients where there is no need to adapt the Patient Specific Implant (PSI) edges

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yau-Zen Chang

Professor

Chang Gung Memorial Hospital

研究点 (1)

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