Department of Bioengineering and Orthopaedic Surgery, Engineering Center for Orthopaedic Research Excellence (E-CORE), University of Toledo, 2801 West Bancroft Street, Toledo, OH, 43606, USA.
Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Building WO 62-2225, Silver Spring, MD, 20993, USA.
Spine Deform. 2024 Jul;12(4):941-952. doi: 10.1007/s43390-024-00846-7. Epub 2024 Mar 27.
Growing rods are the gold-standard for treatment of early onset scoliosis (EOS). However, these implanted rods experience frequent fractures, requiring additional surgery. A recent study by the U.S. Food and Drug Administration (FDA) identified four common rod fracture locations. Leveraging this data, Agarwal et al. were able to correlate these fractures to high-stress regions using a novel finite element analysis (FEA) framework for one patient. The current study aims to further validate this framework through FEA modeling extended to multiple patients.
Three patient-specific FEA models were developed to match the pre-operative patient data taken from both registry and biplanar radiographs. The surgical procedure was then simulated to match the post-operative deformity. Body weight and flexion bending (1 Nm) loads were then applied and the output stress data on the rods were analyzed.
Radiographic data showed fracture locations at the mid-construct, adjacent to the distal and tandem connector across the patients. Stress analysis from the FEA showed these failure locations matched local high-stress regions for all fractures observed. These results qualitatively validate the efficacy of the FEA framework by showing a decent correlation between localized high-stress regions and the actual fracture sites in the patients.
This patient-specific, in-silico framework has huge potential to be used as a surgical tool to predict sites prone to fracture in growing rod implants. This prospective information would therefore be vital for surgical planning, besides helping optimize implant design for reducing rod failures.
生长棒是治疗早发性脊柱侧凸(EOS)的金标准。然而,这些植入的棒经常发生骨折,需要额外的手术。美国食品和药物管理局(FDA)最近的一项研究确定了四个常见的棒断裂位置。利用这些数据,Agarwal 等人能够使用一种新的有限元分析(FEA)框架将这些骨折与一个患者的高应力区域相关联。本研究旨在通过扩展到多个患者的 FEA 建模进一步验证该框架。
为了匹配来自登记处和双平面射线照片的术前患者数据,开发了三个患者特定的 FEA 模型。然后模拟手术过程以匹配术后畸形。然后施加体重和弯曲(1 Nm)载荷,并分析杆上的输出应力数据。
射线照相数据显示在患者中,在中构建处、靠近远端和串联连接器处发生骨折。FEA 的应力分析表明,所有观察到的骨折的这些失效位置与局部高应力区域相匹配。这些结果通过显示局部高应力区域与患者实际骨折部位之间存在相当好的相关性,定性地验证了 FEA 框架的有效性。
这种特定于患者的、基于计算机的框架具有巨大的潜力,可以用作预测生长棒植入物中易发生骨折的部位的手术工具。除了帮助优化植入物设计以减少棒失败之外,这种前瞻性信息对于手术计划也至关重要。