Abane L, Anract P, Boisgard S, Descamps S, Courpied J P, Hamadouche M
Hôpital Cochin, APHP, Université Paris 5, 27 Rue du Faubourg St Jacques, 75014, Paris, France.
Centre Hospitalier Régional Universitaire de Clermont Ferrand, 58 Boulevard de Montalembert, 63003, Clermont Ferrand, France.
Bone Joint J. 2015 Jan;97-B(1):56-63. doi: 10.1302/0301-620X.97B1.34440.
In this study we randomised 140 patients who were due to undergo primary total knee arthroplasty (TKA) to have the procedure performed using either patient-specific cutting guides (PSCG) or conventional instrumentation (CI). The primary outcome measure was the mechanical axis, as measured at three months on a standing long-leg radiograph by the hip-knee-ankle (HKA) angle. This was undertaken by an independent observer who was blinded to the instrumentation. Secondary outcome measures were component positioning, operating time, Knee Society and Oxford knee scores, blood loss and length of hospital stay. A total of 126 patients (67 in the CI group and 59 in the PSCG group) had complete clinical and radiological data. There were 88 females and 52 males with a mean age of 69.3 years (47 to 84) and a mean BMI of 28.6 kg/m(2) (20.2 to 40.8). The mean HKA angle was 178.9° (172.5 to 183.4) in the CI group and 178.2° (172.4 to 183.4) in the PSCG group (p = 0.34). Outliers were identified in 22 of 67 knees (32.8%) in the CI group and 19 of 59 knees (32.2%) in the PSCG group (p = 0.99). There was no significant difference in the clinical results (p = 0.95 and 0.59, respectively). Operating time, blood loss and length of hospital stay were not significantly reduced (p = 0.09, 0.58 and 0.50, respectively) when using PSCG. The use of PSCG in primary TKA did not reduce the proportion of outliers as measured by post-operative coronal alignment.
在本研究中，我们将140例计划接受初次全膝关节置换术（TKA）的患者随机分为两组，分别使用定制截骨导板（PSCG）或传统器械（CI）进行手术。主要结局指标为机械轴，通过站立位长腿X线片上的髋-膝-踝（HKA）角在术后三个月进行测量。测量由一名对器械使用情况不知情的独立观察者进行。次要结局指标包括假体位置、手术时间、膝关节协会（Knee Society）和牛津膝关节评分、失血量及住院时间。共有126例患者（CI组67例，PSCG组59例）获得了完整的临床和影像学数据。其中有88名女性和52名男性，平均年龄69.3岁（47至84岁），平均体重指数（BMI）为28.6 kg/m²（20.2至40.8）。CI组的平均HKA角为178.9°（172.5至183.4），PSCG组为178.2°（172.4至183.4）（p = 0.34）。CI组67例膝关节中有22例（32.8%）、PSCG组59例膝关节中有19例（32.2%）被确定为离群值（p = 0.99）。临床结果无显著差异（分别为p = 0.95和0.59）。使用PSCG时，手术时间、失血量和住院时间并未显著缩短（分别为p = 0.09、0.58和0.50）。在初次TKA中使用PSCG并不能降低通过术后冠状位对线测量的离群值比例。
