Computer Surgical Simulation for Craniofacial Surgery

描述(申请人提供)：颅颌面(CMF)外科领域涉及矫正先天和后天畸形的头骨和面部。这些包括牙面部畸形、先天畸形和肿瘤切除后的缺陷、创伤后缺陷和颞颌关节(TMJ)畸形。在美国，每年都有相当数量的患者因这些类型的缺陷和畸形而接受重建手术。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。这类手术的传统手术计划方法包括体检、平片(头影测量照片)、石膏牙齿模型、三维(3D)计算机体层摄影(CT)扫描，有时还包括基于CT的3D物理模型。不幸的是，这些方法往往不足以计划复杂的颅颌面畸形。在过去的六年里，我们的外科规划实验室已经开发了一个用于计算机辅助手术模拟(CASS)的原型系统。我们的CASS系统的准确性已经在第一阶段研究中得到了证明。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计划复杂的颅颌面手术。此外，这个新开发的软件将按照FDA的要求进行验证？规章制度。最后，我们将继续调查研究人员的临床可行性？卡斯。该项目(第三阶段)的最终目标是将该产品推向市场。颅颌面外科涉及颅面部先天性和获得性畸形的矫正。这些包括牙面部畸形、先天畸形和肿瘤切除后的缺陷、创伤后缺陷和颞颌关节(TMJ)畸形。在美国，每年都有相当数量的患者因这些类型的缺陷和畸形而接受重建手术。

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.