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电子束辐照对全膝关节置换术中常规超高分子量聚乙烯胫骨托板体内性能的影响。

Effect of e-beam sterilization on the in vivo performance of conventional UHMWPE tibial plates for total knee arthroplasty.

机构信息

Department of Orthopaedic Surgery, Mie University, Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie 514-8507, Japan.

Department of Orthopaedic Surgery, Mie University, Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie 514-8507, Japan.

出版信息

Acta Biomater. 2017 Jun;55:455-465. doi: 10.1016/j.actbio.2017.03.040. Epub 2017 Mar 27.

Abstract

UNLABELLED

Although the introduction of highly cross-linked polyethylene is effective in reducing the amount of wear, there are still major concerns regarding the use of this material in total knee arthroplasty (TKA), essentially due to the reduction of fatigue resistance and toughness. Monitoring the in vivo performance of different types of UHMWPE is a much needed task to tackle the lack of information on which should be the most reliable choice for TKA. The present study was aimed at investigating the mid-term degradation of electron beam sterilized conventional UHMWPE tibial plates. Visual inspection enabled to grade the surface damage of 12 retrievals according to the Hood's score: the total wear damage correlates to the in vivo time (Spearman's ρ=0.681, p<0.05) and BMI (ρ=0.834, p<0.001). Surface degradation was less severe than that quantified in similar studies on γ-sterilized UHMWPE. Raman and infra-red spectroscopies were utilized to unfold the microstructural modifications. In the load zone, polyethylene whitened damage regions were noticed in the inserts implanted longer than 1year, in which oxidation index (OI) is clearly higher than 1 (max 8). The maximum OI (ρ=0.802, p<0.005) and α (ρ=0.816, p<0.005) correlate to the implantation time in the load zone. The crystallinity increased along with the extent of oxidation. Concentration of absorbed species from synovial fluid is higher in the contact zone and correlates to maximum OI (Spearman's ρ=0.699, p=0.011). Absorption was promoted in the contact area by the mechanical action of the femoral counterpart and it exacerbated the oxidative degradation in retrievals with high concentration of absorbed species. In the non-load zone, mild but detectable oxidation was observed, probably due to free radicals trapped after sterilization.

STATEMENT OF SIGNIFICANCE

Although several clinical studies on retrieved tibial bearings have been published so far, monitoring and comparing the in vivo performance of different types of UHMWPE is still a much needed task. The present study reports for the first time results on the effect of sterilization by electron beam on the mid-term in vivo performance of conventional UHMWPE tibial plates. In the present investigation, visual inspection of wear damage based on the Hood's scoring method, Raman micro-spectroscopy and Fourier-transformed infrared spectroscopy were utilized to unveil the damage, the microstructural modifications and the oxidation occurred during implantation. The findings of this investigation have been discussed and compared to previous clinical studies on γ-air sterilized, γ-inert sterilized tibial bearings.

摘要

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虽然引入高度交联聚乙烯可有效减少磨损量,但在全膝关节置换术中(TKA)使用这种材料仍存在很大的顾虑,主要是因为疲劳强度和韧性降低。监测不同类型的超高分子量聚乙烯的体内性能是一项非常必要的任务,这是因为缺乏关于 TKA 最可靠选择的信息。本研究旨在研究电子束灭菌常规超高分子量聚乙烯胫骨托的中期降解情况。通过 Hood 评分对 12 个回收物的表面损伤进行分级:总磨损损伤与体内时间相关(Spearman ρ=0.681,p<0.05)和 BMI(ρ=0.834,p<0.001)。表面降解程度低于类似γ-射线灭菌超高分子量聚乙烯研究中量化的程度。拉曼和红外光谱用于揭示微观结构的变化。在负荷区,在植入超过 1 年的植入物中,发现聚乙烯变白的损伤区域,其中氧化指数(OI)明显高于 1(最高 8)。负荷区中最大 OI(ρ=0.802,p<0.005)和α(ρ=0.816,p<0.005)与植入时间相关。结晶度随氧化程度的增加而增加。从滑液中吸收的物质的浓度在接触区较高,并与最大 OI 相关(Spearman ρ=0.699,p=0.011)。在接触区,股骨对应物的机械作用促进了吸收,并且在吸收物质浓度高的回收物中加剧了氧化降解。在非负荷区,观察到轻微但可检测到的氧化,这可能是由于灭菌后自由基被困引起的。

意义声明

尽管迄今为止已经发表了几项关于回收胫骨轴承的临床研究,但监测和比较不同类型的超高分子量聚乙烯的体内性能仍然是一项非常必要的任务。本研究首次报告了电子束灭菌对常规超高分子量聚乙烯胫骨托中期体内性能的影响。在本研究中,基于 Hood 评分法的磨损损伤的目视检查、拉曼微光谱和傅里叶变换红外光谱用于揭示植入过程中的损伤、微观结构变化和氧化。讨论了本研究的结果,并与之前关于γ-空气灭菌、γ-惰性灭菌胫骨轴承的临床研究进行了比较。

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