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[全髋关节置换中最常用的新型超高分子量聚乙烯关节置换插入物的质量比较]

[Comparison of the Quality of the Most Frequently Used New UHMWPE Articulation Inserts of the Total Hip Replacement].

作者信息

Fulín P, Šlouf M, Vlková H, Krejčíková S, Kredatusová J, Pokorný D

机构信息

I. ortopedická klinika 1. lékařské fakulty Univerzity Karlovy a Fakultní nemocnice v Motole, Praha.

出版信息

Acta Chir Orthop Traumatol Cech. 2019;86(2):101-109.

Abstract

PURPOSE OF THE STUDY For an orthopedic surgeon it is difficult or even impossible to estimate the real quality of ultrahigh molecular weight polyethylene (UHMWPE) liners that are used in the total joint replacements (TJR) just on the basis of information given by the manufacturers. At the same time, the quality of the UHMWPE liner can impact strongly on the total lifespan of the implanted TJR. This work aims at independent, objective comparison of properties of the UHMWPE liners for total hip replacements (THR), which are most frequently used in the Czech Republic. MATERIAL AND METHODS We analyzed seventeen most frequently implanted UHMWPE cups of different manufacturers implanted in the Czech Republic between 2014 and 2015 and four control samples prepared by standard industrial-scale procedures according to our instructions, whose modification (crosslinking, thermal treatment, stabilization and sterilization) was known in detail. The UHMWPE polymer was characterized by four independent microscale methods, suitable for relatively small and irregular specimens such as THR cups: infrared microspectroscopy (IR), differential scanning calorimetry (DSC), and thermogravimetric analysis (TGA). RESULTS The employed methods yielded quite complete information about the investigated UHMWPE materials. IR spectra enabled us to calculate oxidation indexes (OI, measure of oxidative damage), trans-vinylene indexes (VI, measure of absorbed radiation dose during crosslinking and/or sterilization) and crystallinity indexes (CI, amount of crystalline phase that strongly influences mechanical performance). DSC curves were employed in calculation of crystallinities (wc, proportional to CI) and melting points (Tm, proportional to the average thickness of crystalline lamellae). MH measurements confirmed that the observed structure changes showed a real impact on mechanical properties. TGA experiments gave rough estimate of stabilization and, consequently, possible long-term oxidation resistance. Significant correlations among oxidative damage (OI), crystallinity (CI, wc) and microhardness (Hv) were statistically proven. The highest oxidative degradation was usually observed in samples thermally treated by annealing and/or sterilized by gamma irradiation. DISCUSSION The results confirmed our expectations that the UHMWPE liners from various manufacturers can be significantly different as far as their molecular structure, supermolecular structure, and mechanical properties are concerned. The differences among the various UHMWPE can be expected to increase after the implantation during in vivo. CONCLUSIONS From the clinical practice point of view, the results showed the following facts: (i) In the field of THR, all manufactures prefer crosslinked types of UHMWPE due to their increased wear resistance; non-crosslinked UHMWPEs are regarded as obsolete. (ii) Most of the manufacturers prefer ethylene oxide or gas plasma sterilization to gamma sterilization because the gammasterilized UHMWPEs exhibit lower long-term oxidation resistance. (iii) Modern trend is the stabilization of UHMWPEs with vitamin E. Key words: UHMWPE, hip replacements, oxidative degradation, infrared spectroscopy, microhardness.

摘要

研究目的 对于骨科医生而言,仅依据制造商提供的信息很难甚至不可能评估用于全关节置换(TJR)的超高分子量聚乙烯(UHMWPE)衬垫的实际质量。同时,UHMWPE衬垫的质量会对植入的TJR的整体使用寿命产生重大影响。本研究旨在对捷克共和国最常用的全髋关节置换(THR)用UHMWPE衬垫的性能进行独立、客观的比较。

材料与方法 我们分析了2014年至2015年间在捷克共和国植入的不同制造商的17个最常用的UHMWPE髋臼杯,以及根据我们的指示通过标准工业规模程序制备的4个对照样品,其改性(交联、热处理、稳定化和灭菌)情况已知。采用四种独立的微观方法对UHMWPE聚合物进行表征,这些方法适用于如THR髋臼杯这样相对较小且不规则的样品:红外显微光谱法(IR)、差示扫描量热法(DSC)和热重分析(TGA)。

结果 所采用的方法提供了有关所研究的UHMWPE材料的相当完整的信息。IR光谱使我们能够计算氧化指数(OI,氧化损伤的度量)、反式亚乙烯基指数(VI,交联和/或灭菌期间吸收辐射剂量的度量)和结晶度指数(CI,强烈影响机械性能的结晶相数量)。DSC曲线用于计算结晶度(wc,与CI成比例)和熔点(Tm,与结晶薄片的平均厚度成比例)。MH测量证实观察到的结构变化对机械性能有实际影响。TGA实验给出了稳定化的粗略估计,从而给出了可能的长期抗氧化性。氧化损伤(OI)、结晶度(CI,wc)和显微硬度(Hv)之间的显著相关性得到了统计学验证。通常在通过退火进行热处理和/或通过伽马辐射灭菌的样品中观察到最高的氧化降解。

讨论 结果证实了我们的预期,即就分子结构、超分子结构和机械性能而言,不同制造商的UHMWPE衬垫可能存在显著差异。各种UHMWPE之间的差异预计在体内植入后会增加。

结论 从临床实践的角度来看,结果表明了以下事实:(i)在THR领域,由于其耐磨性提高,所有制造商都更喜欢交联型UHMWPE;非交联UHMWPE被认为已过时。(ii)大多数制造商更喜欢环氧乙烷或气体等离子体灭菌而不是伽马灭菌,因为经伽马灭菌的UHMWPE长期抗氧化性较低。(iii)现代趋势是用维生素E对UHMWPE进行稳定化处理。

关键词

UHMWPE;髋关节置换;氧化降解;红外光谱;显微硬度

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