University of Birmingham Medical School, Birmingham, United Kingdom.
University of Missouri Department of Orthopaedic Surgery, Columbia, Missouri.
J Knee Surg. 2021 Aug;34(10):1085-1091. doi: 10.1055/s-0040-1701453. Epub 2020 Feb 4.
Customized individually manufactured total knee arthroplasty (CIM-TKA) was developed to improve kinematic total knee arthroplasty (TKA) performance. Component placement accuracy may influence the success of CIM-TKA designs. We performed this study to compare radiographic component alignment and revision rates of a cruciate retaining (CR) CIM-TKA and a contemporary posterior stabilized TKA (PS-TKA). After obtaining Institutional Review Board approval, we identified 94 CR CIM-TKAs (76 patients) and 91 PS-TKAs (82 patients) performed between July 1, 2013 and December 31, 2014 with a minimum 2-year follow-up (mean 41.1 months, range 24-59 months). We performed a retrospective electronic medical record review to identify patient demographic characteristics and revision procedures performed. Postoperative plain radiographs were reviewed to assess component alignment including cruciate ligament imbalance, femoral overhang, and femoral notching. Demographic characteristics, component malalignment, and revision surgery rates were assessed using a student's -test or two-tailed Fisher's exact test, with a -value < 0.05 designating significance. Technical errors were more commonly identified with CR CIM-TKA (29.8 vs. 9.9%, < 0.001), including higher rates of tibiofemoral instability (13.8 vs. 1.1%, < 0.01), femoral notching (12.8 vs. 3.3%, = 0.03), and patellofemoral malalignment (20.2 vs. 7.7%, = 0.02). CR CIM-TKA had more frequent coronal plane malposition (26.6 vs. 9.9%, < 0.01) or sagittal plane reconstruction > 3 degrees outside of an optimized range (20.2 vs. 9.9%, = 0.06). Aseptic revisions occurred more frequently with the CR CIM-TKA design (9.6 vs. 3.3%, = 0.13). Demographic characteristics were not significantly different between the treatment groups. CR CIM-TKA may improve kinematic performance for patients undergoing knee replacement surgery. However, our study observations suggest that careful attention to surgical technique is important for optimizing implant survivorship with the CR CIM-TKA design. Additional study is needed to determine whether higher revision rates identified during this study are related to patient selection, surgical technique, or implant design.
个体化定制的全膝关节置换术（CIM-TKA）的发展是为了提高运动学全膝关节置换术（TKA）的性能。组件的放置精度可能会影响 CIM-TKA 设计的成功。我们进行了这项研究，以比较保留十字韧带（CR）的 CIM-TKA 和现代后稳定 TKA（PS-TKA）的影像学组件对齐和翻修率。在获得机构审查委员会的批准后，我们确定了 94 例 CR CIM-TKA（76 例患者）和 91 例 PS-TKA（82 例患者），这些患者于 2013 年 7 月 1 日至 2014 年 12 月 31 日进行了手术，随访时间至少为 2 年（平均 41.1 个月，范围 24-59 个月）。我们进行了回顾性电子病历审查，以确定患者的人口统计学特征和进行的翻修手术。术后平片评估包括十字韧带失衡、股骨前突和股骨切迹在内的组件对齐情况。使用学生 t 检验或双尾 Fisher 精确检验评估人口统计学特征、组件错位和翻修手术率， -值 < 0.05 表示具有统计学意义。与 PS-TKA 相比，CR CIM-TKA 更常出现技术错误（29.8%对 9.9%， < 0.001），包括更高的胫股关节不稳定率（13.8%对 1.1%， < 0.01）、股骨切迹率（12.8%对 3.3%， = 0.03）和髌股关节对线不良率（20.2%对 7.7%， = 0.02）。CR CIM-TKA 更常出现冠状面错位（26.6%对 9.9%， < 0.01）或矢状面重建超出优化范围 3 度以上（20.2%对 9.9%， = 0.06）。CR CIM-TKA 发生无菌性翻修的频率更高（9.6%对 3.3%， = 0.13）。两组患者的人口统计学特征无显著差异。CR CIM-TKA 可为接受膝关节置换手术的患者改善运动学性能。然而，我们的研究观察表明，对于 CR CIM-TKA 设计，仔细注意手术技术对于优化植入物的存活率非常重要。需要进一步的研究来确定本研究中确定的更高翻修率是否与患者选择、手术技术或植入物设计有关。
