Computer Surgical Simulation for Craniofacial Surgery

描述（由申请人提供）：颅颌面（CMF）外科领域涉及颅骨和面部先天性和后天畸形的矫正。这些包括牙面畸形、先天性畸形、肿瘤消融后的缺损、创伤后缺损和颞下颌关节（TMJ）畸形。在美国，每年都有大量的患者因这些类型的缺陷和畸形接受重建手术。由于颅面骨骼的复杂性，颅面重建手术通常需要广泛的术前计划。这种类型的手术的传统手术计划方法涉及体格检查、X线平片（头影测量X线片）、石膏牙模型、三维（3D）计算机断层扫描（CT）扫描，偶尔还涉及基于CT的3D物理模型。不幸的是，这些方法往往不足以规划复杂的颅颌面畸形。在过去的六年里，我们的手术计划实验室已经开发了一个原型系统的计算机辅助手术模拟（卡斯）。我们的卡斯系统的准确性已在第一阶段研究中得到证实。第二阶段提案的具体目标将是开发一个用户友好的软件包，使外科医生能够从头到尾规划复杂的颅颌面手术。此外，这一新开发的软件将验证后，FDA？规章制度最后，我们将继续调查研究者的临床可行性？卡斯.该项目（第三阶段）的最终目标是将该产品推向市场。颅颌面（CMF）外科领域涉及颅骨和面部先天性和后天畸形的矫正。这些包括牙面畸形、先天性畸形、肿瘤消融后的缺损、创伤后缺损和颞下颌关节（TMJ）畸形。在美国，每年都有大量的患者因这些类型的缺陷和畸形接受重建手术。

DESCRIPTION (provided by applicant): The field of cranio-maxillofacial (CMF) surgery involves the correction of congenital and acquired deformities of the skull and face. These include dentofacial deformities, congenital deformities, and defects after tumor ablation, post-traumatic defects, and deformities of the temporomandibular joint (TMJ). In the United States each year, a significant number of patients undergo reconstructive surgery for these types of defects and deformities. Due to the complex nature of the craniofacial skeleton, craniofacial reconstructive surgery usually requires extensive pre-surgical planning. Traditional surgical planning methods for this type of the surgery involve a physical examination, plain radiographs (cephalometric radiographs), plaster dental models, three-dimensional (3D) computed tomography (CT) scans, and occasionally CT-based 3D physical models. Unfortunately, these methods are often not adequate for planning complex cranio-maxillofacial deformities. Over the last six years, our Surgical Planning Laboratory has developed a prototype system for computer- aided surgical simulation (CASS). The accuracy of our CASS system has been proven in the Phase I study. The specific aim of the Phase II proposal will be to develop a user-friendly software package that will allow surgeons to plan complex cranio-maxillofacial surgeries from beginning to end. In addition, this newly developed software will be validated following the FDA? rules and regulations. Finally, we will continue to investigate the clinical feasibility of the investigators? CASS. The ultimate goal of this project (Phase III) is to take this product to the market. The field of cranio-maxillofacial (CMF) surgery involves the correction of congenital and acquired deformities of the skull and face. These include dentofacial deformities, congenital deformities, and defects after tumor ablation, post-traumatic defects, and deformities of the temporomandibular joint (TMJ). In the United States each year, a significant number of patients undergo reconstructive surgery for these types of defects and deformities.