Andersen Mikkel Rathsach, Yilmaz Müjgan, Winther Nikolaj, Lind Thomas, Schrøder Henrik, Flivik Gunnar Flivik, Mørk Petersen Michael
Department of Orthopedics, Herlev Gentofte Hospital, University of Copenhagen; Department of Orthopedics, Rigshospitalet, University of Copenhagen, Denmark
Department of Orthopedics, Rigshospitalet, University of Copenhagen, Denmark.
Acta Orthop. 2025 Jun 27;96:485-491. doi: 10.2340/17453674.2025.43904.
Backside wear of the polyethylene insert in total knee arthroplasty (TKA) has been described to produce clinically significant levels of polyethylene debris, which can lead to aseptic loosening and osteolysis. Monoblock design eliminates backside wear of the polyethylene and therefore could improve long-term fixation. This randomized clinical trial (RCT) using radiostereometric analysis (RSA) compares micromotion of monoblock and modular polyethylene inserts with 7 years' follow-up.
65 patients (mean age 61 years) were randomized to receive either monoblock (n = 32) or modular (n = 33) uncemented trabecular metal tibial components. 35 patients (monoblock = 18, and modular = 17) completed 7 years' follow-up. The primary endpoint of the study was maximum total point motion (MTPM). Implant translation and rotation are reported as secondary endpoints.
After 84 months, the modular group had a statistically significant higher mean MTPM of 1.17 (95% confidence interval [CI] 0.90-1.41) mm compared with the monoblock group of 0.78 (CI 0.55-0.88) mm (P = 0.02). However, there was no difference in continuous migration (from 12-84 months), which was 0.13 mm in the monoblock group and 0.16 mm in the modular group.
There was significantly lower early migration in the monoblock group compared with the modular group but no difference in continuous migration after 12 months, which confirms the finding of previous publications.
全膝关节置换术(TKA)中聚乙烯衬垫的背面磨损会产生具有临床意义的聚乙烯碎屑,这可能导致无菌性松动和骨溶解。整体式设计可消除聚乙烯的背面磨损,因此可能改善长期固定效果。这项使用放射立体测量分析(RSA)的随机临床试验(RCT)对整体式和模块化聚乙烯衬垫的微动情况进行了7年的随访比较。
65例患者(平均年龄61岁)被随机分为接受整体式(n = 32)或模块化(n = 33)非骨水泥小梁金属胫骨组件。35例患者(整体式 = 18例,模块化 = 17例)完成了7年的随访。该研究的主要终点是最大总点运动(MTPM)。植入物的平移和旋转作为次要终点报告。
84个月后,模块化组平均MTPM为1.17(95%置信区间[CI] 0.90 - 1.41)mm,与整体式组的0.78(CI 0.55 - 0.88)mm相比具有统计学显著差异(P = 0.02)。然而,连续迁移(12 - 84个月)没有差异,整体式组为0.13 mm,模块化组为0.16 mm。
与模块化组相比,整体式组的早期迁移明显更低,但12个月后的连续迁移没有差异,这证实了先前出版物的研究结果。