Hafez Mahmoud A, Jansen Arne, Portheine Frank, Jaramaz Branislav
The Orthopaedic Department, Faculty of Medicine, October 6 University, Giza, Egypt.
Helmholtz-Institute of Biomedical Engineering and SurgiTaix, Aachen, Germany.
Sci Rep. 2025 Jan 10;15(1):1577. doi: 10.1038/s41598-024-77794-9.
Patient-specific templating (PST), which is a sister procedure to patient-specific instrumentation (PSI) but hospital-based, is relatively less complex and less expensive than robotics and navigation. However, there are some concerns about the PST including the process of preoperative planning, 3D printing and material, positioning of PST intraoperatively, availability, and clinical value. The purpose of this study was to validate the technical accuracy and reliability of the PST technique in the lab and to report the outcomes of clinical application. To test the reliability of the PST technique, five observers positioned the PST templates five times over the distal femur and proximal tibial whilst a navigation system was used to measure the level of bone cutting, coronal and sagittal alignment, and rotation in both femur and tibia. The mean alignment error in all planes was 0.67° (maximum 2.5°). Concerning the bone (femoral and tibial) cutting, the mean error was 0.32 mm (maximum 1 mm). The qualitative and quantitative analysis showed an overall agreement between observers (p < 0.05). The laboratory part of this study showed that the positioning of the PST over the proximal tibia and distal femur during TKA is reliable. There were statistically insignificant intraobserver and interobserver variations.
患者特异性模板制作（PST）是与患者特异性器械（PSI）类似但基于医院的操作，相对机器人技术和导航技术而言，其复杂性和成本较低。然而，PST也存在一些问题，包括术前规划过程、3D打印及材料、术中PST的定位、可用性和临床价值。本研究的目的是在实验室中验证PST技术的技术准确性和可靠性，并报告临床应用结果。为测试PST技术的可靠性，五名观察者在使用导航系统测量股骨远端和胫骨近端的截骨水平、冠状面和矢状面排列以及股骨和胫骨旋转的同时，对PST模板进行了五次定位。所有平面的平均排列误差为0.67°（最大2.5°）。关于骨（股骨和胫骨）切割，平均误差为0.32毫米（最大1毫米）。定性和定量分析表明观察者之间总体一致（p < 0.05）。本研究的实验室部分表明，在全膝关节置换术中，PST在胫骨近端和股骨远端的定位是可靠的。观察者内和观察者间的差异无统计学意义。
