Renson Luc, Poilvache Pascal, Van den Wyngaert Hans
RZ St. Trudo Hospital, Department of Orthopaedics and Traumatology, 3800 Sint-Truiden, Belgium.
Hôpital de Braine l'Alleud-Waterloo, 1420 Braine l'Alleud, Belgium.
Knee. 2014 Dec;21(6):1216-20. doi: 10.1016/j.knee.2014.09.008. Epub 2014 Oct 30.
Achieving accurate alignment in total knee arthroplasty (TKA) remains a concern. Patient-specific instrumentation (PSI) produced using preoperative 3D models was developed to offer surgeons a simplified, reliable, efficient and customised TKA procedure.
In this prospective study, 60 patients underwent TKA with conventional instrumentation and 71 patients were operated on using PSI. The primary endpoint was surgical time. Secondary endpoints included operating room (OR) time, the number of instrument trays used and postoperative radiographic limb alignment.
Compared to conventional instrumentation, PSI significantly reduced total surgical time by 8.9 ± 3.3 min (p=0.038), OR time by 8.6 ± 4.2 min (p=0.043), and the number of instrument trays by six trays (p<0.001). Mechanical axis malalignment of the lower limb of >3° was observed in 13% of PSI patients versus 29% with conventional instrumentation (p=0.043). PSI predicted the size of the femoral and tibial components actually used in 85.9% and 78.9% of cases, respectively.
PSI improves alignment, surgical and OR time, reduces the number of instruments trays used compared to conventional instrumentation in patients undergoing TKA and results in fewer outliers in overall mechanical alignment in the coronal plane.
Prospective comparative therapeutic study.
全膝关节置换术(TKA)中实现精确对线仍然是一个令人关注的问题。利用术前三维模型制作的患者特异性器械(PSI)被开发出来,为外科医生提供一种简化、可靠、高效且定制化的TKA手术方法。
在这项前瞻性研究中,60例患者接受了传统器械的TKA手术,71例患者使用PSI进行手术。主要终点是手术时间。次要终点包括手术室(OR)时间、使用的器械托盘数量和术后影像学肢体对线情况。
与传统器械相比,PSI显著缩短了总手术时间8.9±3.3分钟(p=0.038),OR时间8.6±4.2分钟(p=0.043),器械托盘数量减少了6个托盘(p<0.001)。PSI组患者下肢机械轴对线不良>3°的比例为13%,而传统器械组为29%(p=0.043)。PSI分别在85.9%和78.9%的病例中预测了实际使用的股骨和胫骨组件的尺寸。
与接受TKA手术的患者使用传统器械相比,PSI改善了对线、手术和OR时间,减少了器械托盘的使用数量,并且在冠状面整体机械对线方面的异常值更少。
证据级别II:前瞻性对比治疗研究。