Abstract

X-Atlas™ is a new imaging technology intended to advance the state of the art in patient-specific instrumentation. It uses standard AP and lateral radiographs instead of CT or MRI scans to create 3D bone models, which can be used to perform pre-operative surgical planning and fabricate TKA personalized guides. The aim of this study was to validate X-Atlas™ and evaluate the accuracy of personalized guides created with this imaging technology. Its ability to predict implant size was also determined. The accuracy of the X-Atlas™ imaging technology was evaluated by comparing the landmarks of X-Atlas™ 3D Bone models to MRI-reconstructed bone models. The accuracy of PSI guides created with X-Atlas™ (X-PSI™ guides) was evaluated during a validation study (16 specimen knees) and a clinical study (50 patients; Health Canada #CSU2015-12K). Optical navigation was used to measure positioning accuracy. In addition, the ability of X-Atlas™ to predict implant size was assessed. The accuracy of the X-Atlas™ imaging technology was below 0.87 and 1.28 mm for the femoral and tibial landmarks, respectively. The accuracy of X-PSI™ guides to reproduce the pre-operative planned HKA was within ± 3° in 100% and 86.1% of cases, for the laboratory and clinical study respectively, which was significantly better than historical data for conventional instrumentation. X-Atlas™ was able to predict implant size to ± 1 size in 95.6% and 100%, for the femur and tibia component respectively. The X-Atlas™ imaging technology demonstrated excellent accuracy for reconstructing a 3D bone model. The results show that PSI guides created with X-Atlas™ (X-PSI™ guides) provide greater implant positioning accuracy than conventional instrumentation, without the requirement of advanced imaging. Furthermore, the X-Atlas™ imaging technology could effectively predict implant sizing, potentially reducing the number of instrument trays and improving surgical efficiency.

摘要

X-Atlas™ 是一种新的成像技术，旨在推进患者专用仪器的最新技术水平。它使用标准的 AP 和侧位 X 光片代替 CT 或 MRI 扫描来创建 3D 骨骼模型，可用于执行术前手术计划和制作 TKA 个性化指南。本研究的目的是验证 X-Atlas™ 并评估使用该成像技术创建的个性化指南的准确性。还确定了其预测植入物尺寸的能力。X-Atlas™ 成像技术的准确性是通过比较 X-Atlas™ 3D 骨骼模型与 MRI 重建骨骼模型的地标来评估的。在验证研究（16 个膝盖标本）和临床研究（50 名患者；加拿大卫生部 #CSU2015-12K）期间评估了使用 X-Atlas™（X-PSI™ 指南）创建的 PSI 指南的准确性。光学导航用于测量定位精度。此外，还评估了 X-Atlas™ 预测种植体尺寸的能力。X-Atlas™ 成像技术的股骨和胫骨标志的准确度分别低于 0.87 和 1.28 毫米。对于实验室和临床研究，X-PSI™ 导板再现术前计划的 HKA 的准确度分别在 100% 和 86.1% 的情况下在 ± 3° 以内，这明显优于传统器械的历史数据。X-Atlas™ 能够分别预测股骨和胫骨假体的植入物尺寸为 ± 1 尺寸，分别为 95.6% 和 100%。X-Atlas™ 成像技术在重建 3D 骨骼模型方面表现出出色的准确性。结果表明，与传统仪器相比，使用 X-Atlas™ 创建的 PSI 导向器（X-PSI™ 导向器）提供更高的种植体定位精度，无需高级成像。此外，X-Atlas™ 成像技术可以有效预测种植体尺寸，有可能减少器械托盘的数量并提高手术效率。