The Application and Clinical Accuracy of Patient-specific Implants in Genioplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Positional differences of the chin between the plan and postoperative results
研究概览
简要总结
The purpose of this study is to assess the accuracy and clinical validation of patient specific implants (PSI) technique for genioplasty.
详细描述
Chin plays an important role in the lower facial harmony and balance. With the advances in computer-aided surgical simulation (CASS) technology, surgeons are now able to simulate surgical procedures in the computer to achieve the best possible surgical plan. However, CAD/CAM surgical templates do not maximize the potential of CASS technique. Patient specific implants (PSI) has rapidly developed in cranio-maxillofacial surgery in the past few years. However, few studies have introduced PSI technique in osseous genioplasty. The purpose of this study is to assess the accuracy and clinical validation of patient specific implants (PSI) technique in genioplasty for positioning and fixation of the chin segment.
Anticipated 30 patients with chin deformities are enrolled. Virtual planning is performed with the computer-aided surgical simulation method. The 3D printing titanium cutting guide and patient specific plate is involved in this PSI method. The cutting guide is designed to guide the osteotomy and screw holes drilling for the following patient specific plate. And the patient specific plate is used to simultaneously complete the reposition and fixation of the chin. The outcome is evaluated by comparing the plan with actual outcomes.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who were scheduled to undergo genioplasty;
- •patients who were scheduled to undergo CT scan as a part of their diagnosis and treatment;
- •patients who agreed to participate in this study
排除标准
- •craniofacial syndrome;
- •segmental osseous genioplasty;
- •previous osseous genioplasty;
- •previous mandibular trauma;
- •systemic disorders.
研究组 & 干预措施
PSI group
The patient specific implant (PSI) is used to completed the genioplasty.
干预措施: Patient Specific Implant (Device)
结局指标
主要结局
Positional differences of the chin between the plan and postoperative results
时间窗: 2 weeks after the operation
The coordinates of the centroid of three land points on the chin segment was used to calculate the position differences between the plan and postoperative results in X, Y and Z axis.
Orientation differences of the chin between the plan and postoperative results
时间窗: 2 weeks after the operation
The coordinates of three independent points were used to define the orientation of the chin in 3D space. The orientation differences were calculated in pitch (the rotation around the X axis), roll (the rotation around the Y axis), and yaw (the rotation around the Z axis).
次要结局
- time consuming(3 days after the operation)
- economic consuming(3 days after the operation)
研究者
Xudong Wang
Acting chair of Department of Oral and Craniomaxillofacial Surgery
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University