Department of Orthopaedic Surgery, Institute for Locomotion, Aix-Marseille University, Marseille, France,
Knee Surg Sports Traumatol Arthrosc. 2013 Oct;21(10):2213-9. doi: 10.1007/s00167-013-2623-8. Epub 2013 Aug 14.
It was our hypothesis that patient-specific instrumentation (PSI) can improve the accuracy of the rotational alignment in TKA based on the concept of the system and on the potential to clearly identify pre-operatively during planning the classical anatomical landmarks that serve as references to set-up the rotation both for the femur and tibia.
In this prospective comparative randomized study, 40 patients (20 in each group) operated in our institution between September 2012 and January 2013 by the 2 senior authors were included. Randomization of patients into one of the two groups was done by the Hospital Informatics Department with the use of a systematic sampling method. All patients received the same cemented high-flex mobile bearing TKA. In the PSI group, implant position was compared to the planed position using previously validated dedicated software. The position of the implants (frontal and sagittal) was compared in the 2 groups on standard X-rays, and the rotational position was analysed on post-operative CT-scan.
90 % of the patients add <2° or mm of difference between the planned position of the implants and the obtained position, except for the tibial rotation where the variations were much higher. Mean HKA was 179° (171-185) in the PSI group with 4 outliers (2 varus: 171° and 172°:184° and 185°) and 178.3° with 2 outliers (171° and 176°) in the control group. No difference was observed between the two groups concerning the frontal and sagittal position of the implants on the ML and AP X-rays. No significant difference of femoral rotation was observed between the two groups with a mean of 0.4° in the PSI group and 0.2° in the control group (p: n.s). Mean tibial rotation was 8° of internal rotation in the PSI group and 15° of internal rotation in the standard group (p: n.s).
Based on our results, we were unable to confirm our hypothesis as PSI cannot improve rotation in TKA. More work needs to be done to more clearly define the place of PSI in TKA, to keep on improving the accuracy of the system and to better define the individual targets in TKA in terms of frontal, sagittal and rotational positioning of the implant for each patient.
Prospective comparative randomized study, Level II.
我们的假设是，基于系统的概念以及在术前规划中明确识别作为股骨和胫骨旋转定位参考的经典解剖标志的潜力，患者特定的手术工具（PSI）可以提高 TKA 旋转对线的准确性。
在这项前瞻性的随机对照研究中，我们纳入了 2012 年 9 月至 2013 年 1 月期间由两位资深作者在我院进行手术的 40 名患者（每组 20 名）。患者被医院信息部门采用系统抽样方法随机分配到两组之一。所有患者均接受相同的骨水泥高屈曲活动平台 TKA。在 PSI 组中，使用先前验证的专用软件比较植入物的位置与计划位置。在两组中，通过标准 X 射线比较植入物的位置（额状面和矢状面），并在术后 CT 扫描上分析旋转位置。
90%的患者植入物的计划位置与实际位置之间的差异<2°或 mm，除了胫骨旋转的变化较大。PSI 组的平均 HKA 为 179°（171-185），有 4 个离群值（2 个内翻：171°和 172°：184°和 185°），对照组的平均 HKA 为 178.3°，有 2 个离群值（171°和 176°）。在 ML 和 AP X 射线中，两组植入物的额状面和矢状面位置无显著差异。两组股骨旋转无显著差异，PSI 组平均旋转 0.4°，对照组平均旋转 0.2°（p：n.s）。PSI 组胫骨内旋平均 8°，标准组胫骨内旋 15°（p：n.s）。
根据我们的结果，我们无法证实我们的假设，因为 PSI 不能改善 TKA 的旋转。需要进一步研究，以更清楚地确定 PSI 在 TKA 中的地位，不断提高系统的准确性，并更好地定义每个患者植入物的额状面、矢状面和旋转定位的个体目标。
前瞻性随机对照研究，II 级。
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