INTRODUCTION Evidence now exists advocating the use of computer navigation in total knee arthroplasty (TKA). Despite the introduction of new navigation systems into clinical practice no evidence currently exists showing independent verification of their accuracy. The aim of this study was to validate the in vivo accuracy of the Exactech Guided Personalised Surgery (GPS) computer navigation system using a validated computed tomography (CT) measurement of alignment. METHOD Consecutive patients who underwent TKA using the GPS Navigation System at our institution were prospectively recruited. Intraoperative parameters of 3D alignment as measured by the GPS navigation system were recorded and compared against the postoperative measurements of alignment measured using the Perth CT Protocol to assess the accuracy of the GPS navigation system. RESULTS 29 consecutive patients (13 male, 16 female) who underwent TKA were prospectively recruited. Overall, for all measures of 3D alignment the mean difference between intraoperatively recorded and postoperative CT-measured alignment was 1.55° ± 0.22° (95% confidence interval). Individual measurement differences in the femoral prosthesis were: coronal alignment 1.64° ± 0.52°; flexion 2.07° ± 0.55°; rotation 1.38° ± 0.33° Differences in the tibial prosthesis were: coronal alignment 2.03° ± 0.53°; slope 1.14° ± 0.39° The whole limb coronal alignment difference was 2.34° ± 0.83° CONCLUSION: The Exactech GPS Navigation system is very accurate with a high concordance between intraoperative and postoperative measures of alignment and prosthesis positioning. We therefore confidently validate the system and support its continued use in clinical practice. Other navigation systems should undergo a similar validation process.

中文翻译：

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全膝关节置换术中计算机导航的准确性：一项基于计算机断层扫描的前瞻性研究。

引言现在有证据支持在全膝关节置换术（TKA）中使用计算机导航。尽管在临床实践中引入了新的导航系统，但目前尚无证据显示其准确性得到独立验证。这项研究的目的是使用经过验证的计算机断层扫描（CT）对准度来验证Exactech引导的个性化手术（GPS）计算机导航系统的体内准确性。方法前瞻性招募我院使用GPS导航系统进行TKA的连续患者。记录由GPS导航系统测量的术中3D对准的术中参数，并将其与使用Perth CT协议测量的对准的术后测量值进行比较，以评估GPS导航系统的准确性。结果前瞻性研究了连续接受TKA的29例患者（男13例，女16例）。总体而言，对于所有3D对齐方式，术中记录的和术后CT测量的对齐方式的平均差为1.55°±0.22°（95％置信区间）。股骨假体的个体测量差异为：冠状动脉对准1.64°±0.52°；屈曲2.07°±0.55°; 旋转1.38°±0.33°胫骨假体的差异为：冠状位2.03°±0.53°；倾斜度1.14°±0.39°全肢冠状位对准差异为2.34°±0.83°结论：Exactech GPS导航系统非常精确，在术中和术后的对准和假体定位之间具有高度的一致性。因此，我们有信心验证该系统并支持其在临床实践中的继续使用。其他导航系统应经历类似的验证过程。