Pokorný D, Šlouf M, Gajdošová V, Šeděnková I, Vyroubalová M, Němec K, Fulín P
l. ortopedická klinika 1. lékařské fakulty Univerzity Karlovy a Fakultní nemocnice v Motole, Praha.
Ústav makromolekulární chemie Akademie věd České republiky, Praha.
Acta Chir Orthop Traumatol Cech. 2024;91(4):207-216. doi: 10.55095/achot2024/026.
Total joint replacements (TJR) have become the cornerstone of modern orthopedic surgery. A great majority of TJR employs ultrahigh molecular weight polyethylene (UHMWPE) liners. TJR manufacturers use many different types of UHMWPE, which are modified by various combinations of crosslinking, thermal treatment, sterilization and/or addition of biocompatible stabilizers. The UHMWPE modifications are expected to improve the polymer's resistance to oxidative degradation and wear (release of microparticles from the polymer surface). This manuscript provides an objective, non-commercial comparison of current UHMWPE formulations currently employed in total knee replacements.
UHMWPE liners from 21 total knee replacements (TKR) were collected which represent the most implanted liners in the Czech Republic in the period 2020-2021. The UHMWPEs were characterized using several methods: infrared microspectroscopy (IR), non-instrumented and instrumented microindentation hardness testing (MH and MHI), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), and solubility measurements. The above-listed methods yielded quite complete information about the structure and properties of each UHMWPE type, including its potential long-term oxidation resistance.
For each UHMWPE liner, IR yielded information about immediate oxidative degradation (in the form of oxidation index, OI), level of crosslinking (trans-vinylene index, VI) and crystallinity (CI). The MH and MHI testing gave information about the impact of structure changes on mechanical properties. The remaining methods (DSC, TGA, and solubility measurements) provided additional information regarding the structure changes and resistance to long-term oxidative degradation. Statistical evaluation showed significant differences among the samples as well as interesting correlations among the UHMWPE modifications, structural changes, and mechanical performance.
Surprisingly enough, UHMWPE materials from different manufacturers showed quite different properties, including the resistance against the long-term oxidative degradation, which is regarded as one of the main reasons of TJR failures. The most promising UHMWPE types were crosslinked materials with biocompatible stabilizers.
Current UHMWPE liners from different manufactures used in total knee replacements exhibit significantly different structure and properties. From the point of view of clinical practice, the traditional UHMWPE types, which contained residual radicals from irradiation and/or gamma sterilization, showed inferior resistance to oxidative degradation and should be avoided. The best properties were observed in modern UHMWPE types, which combined crosslinking, biocompatible stabilizers, and sterilization by ethylenoxide or gas plasma.
UHMWPE; knee replacements; oxidative degradation; infrared spectroscopy; microhardness.
全关节置换术(TJR)已成为现代骨科手术的基石。绝大多数全关节置换术采用超高分子量聚乙烯(UHMWPE)衬垫。全关节置换术制造商使用许多不同类型的超高分子量聚乙烯,这些超高分子量聚乙烯通过交联、热处理、灭菌和/或添加生物相容性稳定剂的各种组合进行改性。人们期望超高分子量聚乙烯的改性能够提高聚合物的抗氧化降解和磨损性能(聚合物表面微粒的释放)。本文对目前全膝关节置换术中使用的超高分子量聚乙烯配方进行了客观的、非商业性的比较。
收集了21例全膝关节置换术(TKR)的超高分子量聚乙烯衬垫,这些衬垫代表了2020 - 2021年捷克共和国植入最多的衬垫。使用多种方法对超高分子量聚乙烯进行了表征:红外显微光谱法(IR)、非仪器化和仪器化微压痕硬度测试(MH和MHI)、差示扫描量热法(DSC)、热重分析(TGA)和溶解度测量。上述方法提供了关于每种超高分子量聚乙烯类型的结构和性能的相当完整的信息,包括其潜在的长期抗氧化性。
对于每个超高分子量聚乙烯衬垫,红外光谱法得出了关于即时氧化降解(以氧化指数,OI形式)、交联水平(反式亚乙烯基指数,VI)和结晶度(CI)的信息。微压痕硬度测试和仪器化微压痕硬度测试给出了结构变化对机械性能影响的信息。其余方法(差示扫描量热法、热重分析和溶解度测量)提供了关于结构变化和长期抗氧化降解抗性的额外信息。统计评估显示样品之间存在显著差异,以及超高分子量聚乙烯改性、结构变化和机械性能之间有趣的相关性。
令人惊讶的是,不同制造商的超高分子量聚乙烯材料表现出 quite different properties,包括对长期氧化降解的抗性,而长期氧化降解被认为是全关节置换术失败的主要原因之一。最有前景的超高分子量聚乙烯类型是带有生物相容性稳定剂的交联材料。
目前用于全膝关节置换术的不同制造商的超高分子量聚乙烯衬垫表现出显著不同的结构和性能。从临床实践的角度来看, 包含来自辐射和/或伽马灭菌的残留自由基的传统超高分子量聚乙烯类型表现出较差的抗氧化降解抗性,应予以避免。在结合了交联、生物相容性稳定剂以及环氧乙烷或气体等离子体灭菌的现代超高分子量聚乙烯类型中观察到了最佳性能。
超高分子量聚乙烯;膝关节置换术;氧化降解;红外光谱;显微硬度