Clinical Accuracy of Patient-specific Implants in Genioplasty
The Application and Clinical Accuracy of Patient-specific Implants in Genioplasty
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Shanghai、中国
- 招聘中
- Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
-
接触：
- Biao Li, Master
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- craniofacial syndrome;
- segmental osseous genioplasty;
- previous osseous genioplasty;
- previous mandibular trauma;
- systemic disorders.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：PSI group
The patient specific implant (PSI) is used to completed the genioplasty.
|
The patient specific implant is used to simultaneously complete the reposition and fixation of the chin.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Positional differences of the chin between the plan and postoperative results
大体时间：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.
|
2 weeks after the operation
|
|
Orientation differences of the chin between the plan and postoperative results
大体时间：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).
|
2 weeks after the operation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
time consuming
大体时间：3 days after the operation
|
time spending for the virtual planning and the design of the PSI
|
3 days after the operation
|
|
economic consuming
大体时间：3 days after the operation
|
economic cost of the fabrication of the patient specific implant
|
3 days after the operation
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- PSIcmfs03
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
下巴小神经的临床试验
Patient Specific Implant的临床试验
-
Union Hospital, Tongji Medical College, Huazhong...招聘中黑色素瘤 | 肉瘤 | 乳腺癌 | 胶质母细胞瘤 | 大肠癌 | 胰腺癌 | 肺癌 | 头颈部肿瘤中国
-
Sykehuset i Vestfold HFHospital Pharmacy Enterprise, South Eastern Norway完全的
-
Brigham and Women's HospitalGordon and Betty Moore Foundation完全的
-
Brigham and Women's HospitalPatient-Centered Outcomes Research Institute主动，不招人
-
Dana-Farber Cancer Institute主动，不招人
-
Ohio State University Comprehensive Cancer CenterAmerican Cancer Society, Inc.完全的