3D打印截骨导板对全膝关节置换术股骨假体旋转对线的影响

Effect of femoral component rotational alignment in total knee arthroplasty by using 3D-printed patient-specific instruments:a prospective randomized control study

目的:比较在全膝关节置换术(TKA)中使用3D打印个性化截骨导板(PSI)和传统手术器械(CI)在股骨假体旋转对线上的差异。方法:于2018年10月至2019年12月于北京大学第三医院前瞻性连续纳入80例因膝关节骨关节炎行初次单侧TKA的患者,其中女63例,男17例,平均年龄69岁。根据区组随机(区组大小为4)的方法,分为PSI-TKA组和CI-TKA组,每组患者40例。记录并比较两组患者术后股骨假体的旋转角度,旋转对线的偏移率,术后1年随访时的膝关节美国特种外科医院评分(HSS)和西安大略和麦克马斯特大学骨关节炎指数评分(WOMAC)以及膝前痛的发生率。结果:两组患者在术后股骨假体旋转角度上的差异无统计学意义(CI-TKA组0.7°,PSI-TKA组0.6°, P=0.279),但PSI-TKA组患者旋转角度的变异系数低于CI-TKA组(1.50比2.14)。所有患者总体力线偏移(内旋/外旋>2°)率是13.5%,其中CI-TKA组为19.4%,PSI-TKA组为7.9%,差异无统计学意义( P=0.185)。共有6例(8.1%)患者在术后1年随访时出现了膝前痛。两组在术后1年时的膝前痛发生率和膝关节HSS评分及WOMAC总分上差异均无统计学意义(均 P>0.05)。 结论:PSI和传统器械手术一样,可良好地重建TKA术后股骨假体旋转对线,且展现出了减少力线偏移的趋势。

Objective To compare the difference between two total knee arthroplasty(TKA)techniques,patient-specific instrumentation(PSI)and conventional instrumentation(CI),regarding the rotational alignment of femoral components.Methods A prospective,randomized controlled trial in 80 patients with severe knee osteoarthritis who underwent primary unilateral TKA from October 2018 to December 2019 in Peking University Third Hospital was carried out.There were 63 females and 17 males,with an average age of 69 years.The patients were assigned to either PSI-TKA group(n=40)or CI-TKA group(n=40)with bluster random method(block size 4).The femoral component rotation on the transepicondylar axis,the outlier rate of rotational alignment,the rate of anterior knee pain,and the clinical outcomes including HSS and WOMAC score at 1-year follow-up were documented and analyzed.Results Although no significant difference in femoral component rotational alignment was found between the two groups(CI-TKA:0.7°,PSI-TKA:0.6°,P=0.279),the PSI-TKA group achieved less coefficient of variation of rotational alignment(1.50 vs 2.14)and the distributions of the outliers(19.4%vs 7.9%,P=0.185).Six patients(8.1%)experienced anterior knee pain at 1-year follow-up.No significant difference regarding the incidence of anterior knee pain,the HSS,and WOMAC score was found between the two groups one year after the operation(all P>0.05).Conclusions The satisfied postoperative rotational alignment of femoral components can be attained with the application of PSI in comparison with conventional instrumentation.In addition,PSI offers a potential benefit in the reduction of alignment outliers.