Evaluation of Accuracy of Virtual Surgical Planning and Patient Specific Implants in Craniomaxillofacial Reconstruction (Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Distance deviation
研究概览
简要总结
The sample will consist of 10 patients who will need reconstruction of craniomaxillofacial deformities and defects. The patients will be operated in the Maxillofacial and Plastic Surgery Department, Faculty of Dentistry, Alexandria University, Egypt. All patients will be assessed clinically and radiographically using computed tomography (CT) then virtual surgical planning and custom made patient specific implant will be manufactured. Post-operative clinical evaluation will be done and radiographic evaluation of all patients will be done by CT scan
详细描述
The primary outcome of the study is to evaluate the accuracy of virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction based on radiographic measurements to calculate the angulation deviations of anatomic landmarks between the pre-operative virtual plan and the post-operative actual surgical outcome.
The secondary outcome is long term follow up of the patients clinically and radiographically regarding aesthetics, quality of life and post-operative complications.
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
- 年龄范围
- 10 Years 至 47 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reconstruction of craniofacial, midface, and mandibular bony defects and deformities secondary to:
- •Tumor resection (either by immediate or delayed reconstruction).
- •Complex congenital and dentofacial deformities.
排除标准
- •Patients with special needs.
- •Medically compromised patients who are not fit for surgery.
- •Irradiated patients.
研究组 & 干预措施
virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction.
干预措施: virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction (Procedure)
结局指标
主要结局
Distance deviation
时间窗: Immediate post operative
the accuracy of reconstruction, defined as linear deviations of anatomic landmarks between the virtual plan and the actual surgical outcome using CT scans
Angular deviation
时间窗: Immediate post operative
the accuracy of reconstruction, defined as angulation deviations of anatomic landmarks between the virtual plan and the actual surgical outcome using CT scans
次要结局
- Change in post operative aesthetic results of surgery(1 week, 4 weeks, 8 weeks, and 6 months)
- change in Quality of Life (QOL)(1 week, 4 weeks, 8 weeks, and 6 months)
研究者
Hams Hamed Abdelrahman
Lecturer of Dental Public Health and biostatistical consultanat
Alexandria University