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在髋关节模拟器模型中对32毫米传统聚乙烯衬垫和44毫米高度交联聚乙烯衬垫的三体磨粒磨损挑战

Third-body abrasive wear challenge of 32 mm conventional and 44 mm highly crosslinked polyethylene liners in a hip simulator model.

作者信息

Sorimachi T, Clarke I C, Williams P A, Gustafson A, Yamamoto K

机构信息

Peterson Tribology Laboratory Department Joint Research Center, Loma Linda University, Loma Linda, CA 92354, USA.

出版信息

Proc Inst Mech Eng H. 2009 Jul;223(5):607-23. doi: 10.1243/09544119JEIM562.

Abstract

Hip simulator studies have shown that wear in the polyethylene liners used for total hip replacements increased with the larger-diameter femoral balls and could also be exacerbated by third-body abrasion. However, they also indicated that the more highly cross-linked polyethylene (HXPE) bearings were more wear resistant than conventional polyethylene (CXPE) bearings. Unfortunately the HXPE bearings appeared to be particularly sensitive to adverse wear conditions. One simulator study in particular indicated that poly(methyl methacrylate) (PMMA) debris increased wear sixfold by means of two-body abrasive interactions rather than the supposed third-body abrasion or roughening effects of the Co-Cr surfaces. There has been no confirmation of such novel theories. Therefore the goal of this study was to investigate the sensitivity of large-diameter HXPE bearings to the third-body PMMA wear challenge in a hip simulator model. An orbital hip simulator was used in standard test mode with a physiological load profile. The 32 mm control liners were machined from moulded GUR1050 and gamma irradiated to 35 kGy under nitrogen (CXPE). The 44 mm liners were also from moulded blanks, gamma irradiated to 75 kGy, machined to shape, given a proprietary heat treatment, and sterilized by gas plasma (HXPE). As in the published simulator model, the study was conducted in three phases. In phase 1, all cups were run in standard ('clean') lubricant for 1.5 x 10(6) cycles duration. In phase 2, three CXPE cups and six HXPE cups were run for 2 x 10(6) cycles with a slurry of PMMA particles added to the lubricant. In phase 3, the implants were again run in 'clean' lubricant for 2 x 10(6) cycles duration. In addition, three HXPE cups were run as wear controls for 5.5 x 10(6) cycles duration in clean lubricant. In phase-1, the HXPE liners demonstrated twelvefold reduced wear compared with the CXPE controls. The 32 mm and 44 mm Co-Cr balls were judged of comparable roughnesses. However, the surface finish of HXPE liners was superior to that of CXPE liners. In phase-2 abrasion, wear rates increased sixfold and eighty-fold for CXPE and HXPE bearings respectively. These data confirmed that HXPE bearings were particularly sensitive to 'severe' test modes. The Co-Cr balls revealed numerous surface patches representing transferred PMMA with average transient roughness increased to 25 nm and 212 nm for the 32 mm and 44 mm balls respectively. These PMMA patches produced an aggressive two-body abrasion wear of the polyethylene. After cleaning, the ball roughness returned to near normal. Therefore the Co-Cr roughness was not an issue in this severe test mode. In phase 3, the wear decreased to near the index values of phase 1, while liner roughness dropped by more than 90 per cent. The control CXPE liners now demonstrated twice the wear of the HXPE, as would be predicted comparing the diameter and cross-linking algorithms. No previous study has correlated polyethylene roughness profiles to wear performance. In phase 2, PMMA abrasion created significant damage to the polyethylene surfaces. The average roughness Sa of CXPE liners increased to 3.6 microm, a twenty-four-fold increase with some scratches up to 40 microm deep. The HXPE roughness also increased but only to 1.5 microm, a ninefold increase. The scratch indices Sz and Sp for HXPE surfaces were also 50 per cent less severe than on CXPE surfaces. However, within 2 x 10(6) cycles duration of phase 3, all liners had recovered to virtually their original surface finish in phase 1. In all test phases, the surface finish of the HXPE liners remained superior to control liners. These experimental data confirmed many of the results from the previous simulator study with the PMMA abrasion models. Thus the 44 mm liners appeared an excellent clinical alternative to the smaller ball designs used in total hip replacements.

摘要

髋关节模拟器研究表明,用于全髋关节置换的聚乙烯衬垫的磨损随着股骨球直径的增大而增加,并且三体磨损也会加剧这种情况。然而,研究还表明,高度交联聚乙烯(HXPE)轴承比传统聚乙烯(CXPE)轴承更耐磨。不幸的是,HXPE轴承似乎对不利的磨损条件特别敏感。一项模拟器研究特别指出,聚甲基丙烯酸甲酯(PMMA)碎屑通过双体磨料相互作用使磨损增加了六倍,而不是通过钴铬表面的所谓三体磨损或粗糙化作用。尚未有对这种新理论的证实。因此,本研究的目的是在髋关节模拟器模型中研究大直径HXPE轴承对三体PMMA磨损挑战的敏感性。使用轨道式髋关节模拟器,采用标准测试模式和生理负荷曲线。32毫米的对照衬垫由模制的GUR1050加工而成,并在氮气环境下γ辐照至35千戈瑞(CXPE)。44毫米的衬垫也由模制坯料制成,γ辐照至75千戈瑞,加工成型,进行专有热处理,并通过气体等离子体灭菌(HXPE)。与已发表的模拟器模型一样,该研究分三个阶段进行。在第1阶段,所有髋臼杯在标准(“清洁”)润滑剂中运行1.5×10⁶个循环周期。在第2阶段,三个CXPE髋臼杯和六个HXPE髋臼杯在润滑剂中添加PMMA颗粒的浆料的情况下运行2×10⁶个循环周期。在第3阶段,植入物再次在“清洁”润滑剂中运行2×10⁶个循环周期。此外,三个HXPE髋臼杯作为磨损对照在清洁润滑剂中运行5.5×10⁶个循环周期。在第1阶段,HXPE衬垫的磨损比CXPE对照减少了12倍。32毫米和44毫米的钴铬球的粗糙度被判定相当。然而,HXPE衬垫的表面光洁度优于CXPE衬垫。在第2阶段的磨损试验中,CXPE和HXPE轴承的磨损率分别增加了六倍和八十倍。这些数据证实了HXPE轴承对“严苛”测试模式特别敏感。钴铬球表面出现了许多代表转移的PMMA的斑块,32毫米和44毫米球的平均瞬态粗糙度分别增加到25纳米和212纳米。这些PMMA斑块对聚乙烯产生了剧烈的双体磨料磨损。清洗后,球的粗糙度恢复到接近正常水平。因此,在这种严苛的测试模式下,钴铬的粗糙度不是问题。在第3阶段,磨损降至接近第1阶段的指标值,而衬垫粗糙度下降了90%以上。对照CXPE衬垫现在的磨损是HXPE的两倍,这与比较直径和交联算法所预测的结果一致。以前没有研究将聚乙烯粗糙度轮廓与磨损性能相关联。在第2阶段,PMMA磨损对聚乙烯表面造成了严重损伤。CXPE衬垫的平均粗糙度Sa增加到3.6微米,增加了24倍,有些划痕深度达40微米。HXPE的粗糙度也增加了,但仅增加到1.5微米,增加了9倍。HXPE表面的划痕指数Sz和Sp也比CXPE表面低50%。然而,在第3阶段的2×10⁶个循环周期内,所有衬垫在第1阶段几乎恢复到了原来的表面光洁度。在所有测试阶段,HXPE衬垫的表面光洁度仍然优于对照衬垫。这些实验数据证实了先前使用PMMA磨损模型的模拟器研究的许多结果。因此,44毫米的衬垫似乎是全髋关节置换中使用的较小球设计的一种优秀临床替代方案。

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