2 种非骨水泥弹性同质性一体式髋臼组件的 RCT 2 年结果:与超高相对分子质量聚乙烯相比,维生素 E 共混的高交联聚乙烯具有更低的磨损率。
2-year results of an RCT of 2 uncemented isoelastic monoblock acetabular components: lower wear rate with vitamin E blended highly cross-linked polyethylene compared to ultra-high molecular weight polyethylene.
机构信息
Clinical Orthopedic Research Center-mN, Zeist, the Netherlands.
Department of Orthopedic Surgery, Diakonessenhuis, Utrecht, the Netherlands.
出版信息
Acta Orthop. 2020 Jun;91(3):254-259. doi: 10.1080/17453674.2020.1730073. Epub 2020 Feb 26.
The long-term survival of arthroplasty components may be limited by polyethylene wear-related problems such as periprosthetic osteolysis and aseptic loosening. Highly cross-linked polyethylene (HXLPE) blended with vitamin E was introduced to improve oxidative stability and to avoid long-term embrittlement. This study clinically compares the tribological behavior and clinical outcome of vitamin E blended HXLPE with ultra-high molecular weight polyethylene (UHMWPE) in an isoelastic monoblock cup for uncemented total hip arthroplasty. - In this randomized controlled trial (RCT), 199 patients were included: 102 patients received the vitamin E blended HXLPE cup, 97 patients the UHMWPE cup. Clinical and radiographic parameters were obtained preoperatively, directly postoperative and at 3, 12, and 24 months. Wear rates were compared using the mean linear femoral head penetration (FHP) rate. - 188 patients (94%) completed the 2-year follow-up. Mean patient satisfaction was higher in the vitamin E blended HXLPE group (8.9 [1]) than in in the control group (8.5 [2], p = 0.03). The Harris Hip Score (HHS) was higher in the vitamin E blended HXLPE group (95 [8]) than in the control group (92 [11], p = 0.3). The FHP rate was lower in the vitamin E blended HXLPE group: 0.046 mm/year compared with 0.056 mm/year in the control group (p = 0.05). No adverse reactions associated with the clinical application of vitamin E blended HXLPE were observed during follow-up, with an excellent 2-year survival to revision rate of 98% for both cups. - This study shows the superior performance of the HXLPE blended with vitamin E acetabular cup with lower linear femoral head penetration rates and better clinical results compared with the UHMWPE acetabular cup after 2 years.
摘要
关节置换部件的长期存活率可能受到与聚乙烯磨损相关的问题的限制,例如假体周围骨溶解和无菌性松动。高交联聚乙烯(HXLPE)与维生素 E 混合以提高氧化稳定性并避免长期脆化。本研究临床比较了维生素 E 混合 HXLPE 与超高分子量聚乙烯(UHMWPE)在非骨水泥全髋关节置换的等弹性单体杯中的摩擦学行为和临床结果。 - 在这项随机对照试验(RCT)中,纳入了 199 名患者:102 名患者接受了维生素 E 混合 HXLPE 杯,97 名患者接受了 UHMWPE 杯。在术前、直接术后以及 3、12 和 24 个月时获得了临床和影像学参数。使用平均线性股骨头穿透(FHP)率比较了磨损率。 - 188 名患者(94%)完成了 2 年随访。维生素 E 混合 HXLPE 组的患者满意度(8.9 [1])高于对照组(8.5 [2],p = 0.03)。维生素 E 混合 HXLPE 组的髋关节 Harris 评分(HHS)(95 [8])高于对照组(92 [11],p = 0.3)。维生素 E 混合 HXLPE 组的 FHP 率较低:0.046 mm/年,而对照组为 0.056 mm/年(p = 0.05)。在随访期间,未观察到与维生素 E 混合 HXLPE 临床应用相关的不良反应,两种杯的 2 年修订后生存率均为 98%。 - 本研究表明,与 UHMWPE 髋臼杯相比,在 2 年后,维生素 E 混合 HXLPE 髋臼杯具有更低的线性股骨头穿透率和更好的临床结果。