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目的:探讨临床数字化导航模板辅助全膝关节置换的可行性和准确性。方法招募20例(男8例,女12例)膝骨性关节炎患者。采集患者下肢全长MRI扫描数据,利用逆向工程软件对MRI数据进行处理,计算机内设计得到一款与股骨远端和胫骨近端匹配的可定位截骨平面和外旋轴的导航模板,最后通过快速成型机制作模板实物用于临床手术操作。手术由同一位具有关节置换经验的骨科医生行全膝关节置换手术。术前观察导航模板与股骨髁和胫骨平台匹配性,术后通过CT扫描检测截骨的准确性。结果导航模板与股骨髁和胫骨平台贴合紧密,无明显移动;所有患者股骨远端和胫骨近端截骨面与下肢机械轴基本垂直,外旋轴定位精确,股骨后髁截骨面与通髁轴保持平行。结论数字化导航模板辅助全膝关节置换具有安全可行,手术操作简单,截骨力线准确。“,”Objective To investigate the accuracy and feasibility of total knee arthroplasty assisted by the navigation templates in clinic. Methods Twenty patients (8 male, 12 female) with knee arthritis requiring arthroplasty were recruited. Volumetric MRI scan was performed on each desired lower limb and a 3D reconstruction model was generated from the scan data. Using reverse engineering technique, anavigational template is designed with a surface that matches the distal femur and proximal tibia. The templatewas manufactured using rapid prototyping technique for clinical use. The operation was designed by the same doctor with experience in joint replacement. The compatibility of the navigation template with tibial and femoral condyles was examined preoperatively. After surgery, the positions of the prosthesis were evaluated using CT scan. Results Each navigational template was found to fit its corresponding biomodel appropriately, and there was no significant free motion of the template. All the cut surfaces were nearly perpendicular to the mechanical alignment, the rotating axis was located accurately and resection of posterior surface was parallel to the transepicondylar axis. Conclusion Total knee replacement assisted digital navigation template is safe and feasible, simple in operation, and accurate in osteotomy.