Fulín P, Pokorný D, Šlouf M, Nevoralová M, Vacková T, Dybal J, Kaspříková N, Landor I
I. ortopedická klinika 1. lékařské fakulty Univerzity Karlovy v Praze a Fakultní nemocnice Motol, Praha.
Acta Chir Orthop Traumatol Cech. 2016;83(3):155-62.
PURPOSE OF THE STUDY Ultrahigh molecular weight polyethylene (UHMWPE) is today the most frequently used bearing surface in total joint replacements (TJR) because of its properties, i.e., excellent biocompatibility, good mechanical and tribological performance and high wear resistance. UHMWPE liners are the most loaded TJR components and, therefore, their properties are decisive for TJR longevity. This study had three objectives: 1) to evaluate the oxidative degradation of explanted UHMWPE components; 2) to look for a statistically significant relationship between the extent of oxidative degradation and the durability of joint replacements; and 3) to investigate whether the durability of a TJR was related to the type of sterilisation used in manufacture. MATERIAL AND METHODS The study included 26 acetabular components obtained at revision arthroplasty between 2004 and 2013 from patients in whom a Beznoska/Poldi total hip replacement was used in the period from 1977 to 2002. The average age of the patients at the time of primary implantation was 57.9 years, the average longevity of the components removed was 18.63 years (range, 6.9 to 27.9 years). Samples of worn out and unworn areas from explanted components were processed in a three-step procedure in order to finally obtain 2-mm microtome sections. These were studied by infrared microspectroscopy. Oxidative damage to UHMWPE was determined as the oxidation index (OI); radiation damage to UHMWPE during sterilization was evaluated as the transvinylene index (VI); oxidation-induced changes in the polymer structure and its properties were characterised as the crystallinity index (CI); and local changes in mechanical properties due to oxidative degradation were assessed as microhardness (MH). Spearman's correlation coefficient and the Wilcoxon two-sample test were used for statistical analysis. RESULTS The OI values (average and maximum) in both worn out and unworn surface areas were related to component longevity. The difference between the oxidation index of ruptured components and that of the other components was statistically significant. Significant differences were also found between the average and maximum OI values of worn out areas and those of unworn surfaces. The relationship between the average oxidation index in both the unworn and worn out areas of UHMWPE components and the longevity of cracked components was statistically significant. DISCUSSION Our results show that the OI values obtained by microspectroscopy correlated with both the microscopic damage and the longevity of UHMWPE liners and the correlation was statistically significant also in relation to the longevity of total replacements. Relationships amongst OI, VI, CI and MH values as well as their relation to failure and longevity of total replacements are discussed. CONCLUSIONS It can be concluded that infrared microspectroscopic measurement of OI values is a simple and fast method to characterise UHMWPE liners. In addition, the IR spectra also show other supplementary characteristics, such as VI and CI indices. These values provide information on the quality of various UHMWPE types currently used in TJR surgery. The types of UHMWPE which exhibit high oxidative degradation should be avoided in clinical practice due to increased risk of early TJR failure. Responsible orthopedic surgeons should be aware of this fact and, if possible, collaborate with an independent, noncommercial laboratory in order to evaluate the quality of various UHMWPE liners used in their hospitals.
UHMWPE, oxidation, total joint replacement, infrared spectroscopy, microhardness.
研究目的 超高分子量聚乙烯(UHMWPE)因其具有优异的生物相容性、良好的机械和摩擦学性能以及高耐磨性等特性,如今是全关节置换术(TJR)中最常用的承重表面。UHMWPE衬垫是TJR中负荷最大的部件,因此其性能对TJR的使用寿命起决定性作用。本研究有三个目标:1)评估取出的UHMWPE部件的氧化降解情况;2)寻找氧化降解程度与关节置换耐久性之间的统计学显著关系;3)研究TJR的耐久性是否与制造过程中使用的灭菌类型有关。材料与方法 本研究纳入了26个髋臼部件,这些部件于2004年至2013年在翻修关节成形术中获取,来自于1977年至2002年期间接受Beznoska/Poldi全髋关节置换的患者。初次植入时患者的平均年龄为57.9岁,取出部件的平均使用寿命为18.63年(范围为6.9至27.9年)。对取出部件的磨损和未磨损区域的样本进行三步处理,最终获得2毫米的切片。通过红外显微光谱对这些切片进行研究。UHMWPE的氧化损伤以氧化指数(OI)确定;灭菌过程中UHMWPE的辐射损伤以反式亚乙烯基指数(VI)评估;聚合物结构及其性能的氧化诱导变化以结晶度指数(CI)表征;氧化降解导致的机械性能局部变化以显微硬度(MH)评估。采用Spearman相关系数和Wilcoxon双样本检验进行统计分析。结果 磨损和未磨损表面区域的OI值(平均值和最大值)均与部件寿命相关。破裂部件的氧化指数与其他部件的氧化指数之间的差异具有统计学意义。磨损区域和未磨损表面的平均OI值和最大OI值之间也存在显著差异。UHMWPE部件未磨损和磨损区域的平均氧化指数与破裂部件寿命之间的关系具有统计学意义。讨论 我们的结果表明,通过显微光谱获得的OI值与UHMWPE衬垫的微观损伤和寿命相关,并且与全关节置换的寿命也具有统计学显著相关性。讨论了OI、VI、CI和MH值之间的关系以及它们与全关节置换失败和寿命的关系。结论 可以得出结论,通过红外显微光谱测量OI值是表征UHMWPE衬垫的一种简单快速的方法。此外,红外光谱还显示出其他补充特征,如VI和CI指数。这些值提供了有关目前TJR手术中使用的各种UHMWPE类型质量的信息。由于早期TJR失败风险增加,临床实践中应避免使用表现出高氧化降解的UHMWPE类型。负责任的骨科医生应意识到这一事实,并在可能的情况下与独立的非商业实验室合作,以评估其医院使用的各种UHMWPE衬垫的质量。关键词:UHMWPE、氧化、全关节置换、红外光谱、显微硬度