In response to the growing demand for precise and affordable solutions for Image-Guided Spine Surgery (IGSS), this paper presents a comprehensive development of a Robot-Assisted and Navigation-Guided IGSS System. The endeavor involves integrating cutting-edge technologies to attain the required surgical precision and limit user radiation exposure, thereby addressing the limitations of manual surgical methods. We propose an IGSS workflow and system architecture employing a hybrid-layered approach, combining modular and integrated system architectures in distinctive layers to develop an affordable system for seamless integration, scalability, and reconfigurability. We developed and integrated the system and extensively tested it on phantoms and cadavers. The proposed system's accuracy using navigation guidance is 1.020 mm, and robot assistance is 1.11 mm on phantoms. Observing a similar performance in cadaveric validation where 84% of screw placements were grade A, 10% were grade B using navigation guidance, 90% were grade A, and 10% were grade B using robot assistance as per the Gertzbein-Robbins scale, proving its efficacy for an IGSS. The evaluated performance is adequate for an IGSS and at par with the existing systems in literature and those commercially available. The user radiation is lower than in the literature, given that the system requires only an average of 3 C-Arm images per pedicle screw placement and verification

翻译：为应对图像引导脊柱手术（IGSS）对精准且经济解决方案日益增长的需求，本文提出了一套机器人辅助与导航引导IGSS系统的完整开发方案。本研究通过整合前沿技术，在实现所需手术精度的同时降低用户辐射暴露，从而弥补手动手术方法的局限性。我们提出了一种采用混合分层方法的IGSS工作流与系统架构，将模块化与集成式系统架构在特定层级相结合，以开发出兼具无缝集成、可扩展性与可重构性的经济型系统。我们完成了系统的开发与集成，并在体模及尸体标本上进行了广泛测试。在体模实验中，所提系统在导航引导下的精度为1.020毫米，机器人辅助下的精度为1.11毫米。尸体验证中观察到相似性能：根据Gertzbein-Robbins分级标准，导航引导下84%的螺钉置入为A级、10%为B级，机器人辅助下90%为A级、10%为B级，证明了该系统在IGSS中的有效性。其评估性能足以满足IGSS需求，且与文献及现有商用系统相当。由于该系统平均仅需每个椎弓根螺钉置入及验证过程中拍摄3张C臂图像，用户辐射暴露水平低于文献报道值。