EAGER: Developing Deformity-Specific Computational Models for Evaluating Novel Surgical Interventions for Treating Scoliosis in Pediatric Subjects

青少年脊柱侧弯(脊柱弯曲)导致的脊柱和肋骨笼畸形可能会造成毁灭性的后果，包括严重的活动受限、疼痛和肺功能问题。虽然脊柱融合手术是矫正脊柱侧弯畸形的黄金标准，但患者的结果通常很差，因为融合手术不支持脊柱的持续生长，这是这一人群所期望的。目前缺乏青少年身体脊柱侧弯标本和脊柱侧弯的计算模型，这严重限制了改进的手术和器械干预治疗脊柱侧弯的系统工程。该项目正在开发和验证青少年、脊柱侧弯和胸腔的计算机模型，然后通过优化Globus Medical，Inc.的新型脊柱畸形矫正系统，在医疗器械设计过程中演示此类畸形专用模型的可行性。脊柱侧弯专用计算机模型将作为预测工具，可靠地指导手术干预的设计、位置、时机和方法。本研究开发的建模和模拟工具将显著减少设计、测试和实施研究性畸形矫正装置所需的时间，从而提高脊柱侧弯患者的生活质量。除了研究合作，该项目还将本科生和研究生的培训整合到研究项目中，并为他们提供与一家医疗器械公司互动和实习的机会。这项研究项目追求三个具体目标，以实现开发和验证青少年脊柱侧弯模型的总体目标。1)本项目建立了10岁正常胸腰椎(带骨盆)和肋骨的有限元模型模板，并使用成人身体标本的生物力学测试的体外运动学数据来验证该模型。2)研究小组正在为Lenke 1AN曲线型开发特定畸形的胸腰椎(带骨盆)和肋骨笼有限元模型，并使用先前从青少年脊柱侧弯收集的活体脊柱运动范围数据来验证该模型。3)与Globus Medical，Inc.合作，研究团队正在进行一项可行性研究，将经过验证的针对畸形的模型应用于传统脊柱侧弯植入物的设计和位置优化，以及一种新型的、有利于生长的脊柱畸形矫正系统。在完成拟议的目标后，将为有效地整合医学图像处理、计算建模以及脊柱侧弯治疗的设备设计和测试奠定基础。

Spinal and rib cage deformities that result from scoliosis (curvature of the spine) in adolescents can have devastating consequences, including severe restrictions in mobility, pain, and problems with lung function. While spinal fusion surgery is the gold-standard for correcting scoliotic spine deformity, patient outcomes are generally poor as the fusion does not support the continued growth of the spine that is expected in this population. There is currently a lack of both adolescent cadaveric scoliotic spine specimens and computational models of the scoliotic spine, which severely limits the systematic engineering of improved surgical and device interventions for treating scoliosis. This project is developing and validating computer models of the adolescent, scoliotic spine and rib cage and then demonstrating the feasibility of such deformity-specific models in the medical device design process by optimizing novel spine deformity correction systems from Globus Medical, Inc. The scoliotic deformity-specific computer models will serve as predictive tools to reliably guide the design, placement, timing and method of surgical intervention. The modeling and simulation tools developed in this study will significantly reduce the time needed to design, test and implement investigational deformity correction devices, which will subsequently improve the quality of life for individuals with scoliosis. In addition to the research collaboration, this project is integrating undergraduate and graduate student training into the research project and providing them with opportunities for interaction and internships with a medical device company. This research project is pursuing three specific objectives to accomplish the overall goal of developing and validating a model of the adolescent, scoliotic spine. 1) This project is creating a finite element model template of the normal 10-year-old thoracolumbar spine (with pelvis) and rib cage and validating this model using in vitro kinematic data from biomechanical testing of adult cadaveric specimens. 2) The research team is developing a deformity-specific thoracolumbar spine (with pelvis) and rib cage finite element model for the Lenke 1AN curve type and validating this model using in vivo spine range of motion data previously collected from adolescents with scoliosis. 3) In collaboration with Globus Medical, Inc., the research team is conducting a feasibility study to apply the validated deformity-specific model for the design and placement optimizations of conventional scoliosis implants and a novel, growth-friendly spine deformity correction system. Upon completion of the proposed objectives, the foundation will be laid to effectively integrate medical image processing, computational modeling, and device design and testing for scoliosis treatment.