Analysis and evaluation of a biomedical polycarbonate urethane tested in an in vitro study and an ovine arthroplasty model. Part II: in vivo investigation.

Analysis and evaluation of a biomedical polycarbonate urethane tested in an in vitro study and an ovine arthroplasty model. Part II: in vivo investigation.
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DOI:
10.1016/j.biomaterials.2004.02.064
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发表时间:
2005-02
期刊:
影响因子:
14
通讯作者:
I. Khan;N. Smith;E. Jones;D. Finch;R. Cameron
I. Khan;N. Smith;E. Jones;D. Finch;R. Cameron
中科院分区:
工程技术1区
文献类型:
--
作者:
I. Khan;N. Smith;E. Jones;D. Finch;R. Cameron

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聚氨酯(PU)弹性体Corethane 80 A(Corvita)被认为是新型全髋关节置换术中的髋臼关节面材料。在体外研究其生物稳定性(分析和评价在体外研究和绵羊关节成形术模型中测试的生物医学聚碳酸酯聚氨酯。第一部分:材料选择和评价,Biomaterials,印刷中)以及三种其他市售生物医学PU:Pellethane 2363- 80 A(DOW Chemical),一种基于聚环氧乙烷的PU,PHMO-PU(CSIRO,未作为商业产品提供)和ChronoFlex AL-80 A(CSIRO Tech)。根据体外研究,Corethane 80 A显示出最佳的耐水解、ESC、MIO和钙化性,其次是ChronoFlex 80 A和PHMO-PU,Pellethane 80 A最不稳定。在体外研究的基础上,后续体内研究(本文报告)评估了Corethane 80 A作为原型顺应性层髋臼杯中的承重层,在全功能绵羊全髋关节置换术(THA)模型中。使用一系列分析和物理测试方法,包括机械测试,差示扫描量热法,傅立叶变换红外光谱和环境扫描电子显微镜,对回收杯中的PU降解进行了分析。Corethane 80 A在THA模型中功能良好,取出的髋关节髋臼杯的关节面在体内3年后没有明显的生物降解或磨损损伤迹象。本研究的结果为结合Corethane 80 A顺应性关节面层的髋臼杯的生物稳定性和有效性提供了令人信服的证据。
The polyurethane (PU) elastomer Corethane 80A (Corvita) is being considered as the acetabular bearing material in a novel total replacement hip joint. Its biostability was investigated in vitro (Analysis and evaluation of a biomedical polycarbonate urethane tested in an in vitro study and an ovine arthroplasty model. Part I: material selection and evaluation, Biomaterials, in press) together with three other commercially available biomedical PUs: Pellethane 2363-80A (DOW Chemical), a polyhexamethylene oxide based PU, PHMO-PU (CSIRO, not supplied as a commercial product) and ChronoFlex AL-80A (CardioTech). From the in vitro studies, Corethane 80A displayed the best overall resistance to hydrolysis, ESC, MIO and calcification, followed by ChronoFlex 80A and PHMO-PU, with Pellethane 80A being the least stable. Building on the in vitro investigation, the follow-up in vivo study (reported here) assessed Corethane 80A as the bearing layer in a prototype compliant layer acetabular cup, in a fully functioning ovine total hip arthoplasty (THA) model. PU degradation in the retrieved cups was analysed using a range of analytical and physical-testing methods including mechanical testing, differential scanning calorimetry, Fourier transform infrared spectroscopy and environmental scanning electron microscopy. The Corethane 80A functioned well in the THA model, with the bearing surfaces of the retrieved hip cups showing no significant evidence of biodegradation or wear damage after 3 years in vivo. The findings in this study provide compelling evidence for the biostability and effectiveness of acetabular cups incorporating a Corethane 80A compliant bearing layer.