Flapless Zygomatic Implants Robot-assisted Placement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Variation rate between theoretical intraoperative position and post-operative zygomatic implants position
研究概览
简要总结
Zygomatic implants are indicated for the rehabilitation of the severely atrophic maxilla. Similar to standard implant placement, gaining an optimal position of the zygomatic implants is essential for a predictable prosthetic-driven treatment outcome.
However, there is no effective mechanism to physically control the drilling trajectory for the zygomatic implants. Therefore, deviation between the actual and planned implant position is inevitable.
This approach is technically difficult, and is performed by an experienced surgeon.
The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics. In this project, a robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess.
Path planning will be carried out on a pre-operative scanner. The ROSA robot (Zimmer®) will guide the several drillings steps. Placement of the zygomatic implant will be performed manually.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from Maxillary edentulism with severe bone resorption
- •Patients suffering from maxillary edentulism post maxillary defect (carcinologic or traumatic) and free flap reconstruction
- •Patients suffering from post-maxillectomy buccosinusal communication.
- •Age ≥ 18 years old
- •Having signed the informed consent
排除标准
- •Patients suffering from chronic sinusitis
- •Patients refusing ROSA robot-guided surgery (unsigned informed consent).
- •Pregnant and nursing women
结局指标
主要结局
Variation rate between theoretical intraoperative position and post-operative zygomatic implants position
时间窗: one day
The accuracy of zygomatic implants positioning will be evaluated by comparing the theoretical intraoperative position and the actual post-operative position by image fusion.
次要结局
未报告次要终点