Zhang Min, Wang Jia-Yu, Su Jian, Wang Jian-Jun, Yan Shi-Tong, Luan Yi-Chao, Cheng Cheng-Kung
Beijing Advanced Innovation Centre for Biomedical Engineering, School of Biological Science and Medical Engineering, Beihang University, Beijing 100083, China.
Beijing Institute of Medical Device Testing, Beijing 101111, China.
Polymers (Basel). 2021 Jun 2;13(11):1847. doi: 10.3390/polym13111847.
the wear of tibial insert is still one of primary factors leading to failure of total knee arthroplasty (TKA). Dodecyl gallate (DG) has shown improvements in the oxidation stability of highly cross-linked polyethylene (HXLPE). This study aimed to assess the application of HXLPE supplemented with DG (HXLPE-DG) on the tibial insert in TKA concerning the wear resistance and the potential impact on implant fixation; Methods: tibial inserts made of HXLPE-DG were subjected to a 3 million loading-cycle wear test following ISO 14243-1:2009. The loss of mass and wear rate of the tibial inserts were calculated. The quantity, size,- and shape of wear particles were recorded; Results: the test specimens lost an average mass of 16.00 mg ± 0.94 mg, and were on an average wear rate of 3.92 mg/million cycles ± 0.19 mg/million cycles. The content of wear particles in the calf serum medium was 3.94 × 10 particles/mL ± 3.93 × 10 particles/mL, 96.66% ± 0.77% of the particles had an equivalent circular diameter less than 0.5 μm. The aspect ratio of wear particles was 1.40 (min: 1.01; max: 6.42).
HXLPE-DG displayed advantages over the commonly used materials for tibial inserts and presented the potential of application in TKA.
胫骨假体磨损仍是导致全膝关节置换术（TKA）失败的主要因素之一。没食子酸十二酯（DG）已显示出在提高高度交联聚乙烯（HXLPE）氧化稳定性方面的作用。本研究旨在评估添加DG的HXLPE（HXLPE-DG）在TKA胫骨假体上的应用，涉及耐磨性及对植入物固定的潜在影响。方法：按照ISO 14243-1:2009对由HXLPE-DG制成的胫骨假体进行300万次加载循环磨损试验。计算胫骨假体的质量损失和磨损率。记录磨损颗粒的数量、大小和形状。结果：测试样本平均质量损失为16.00 mg±0.94 mg，平均磨损率为3.92 mg/百万次循环±0.19 mg/百万次循环。小牛血清培养基中磨损颗粒的含量为3.94×10颗粒/mL±3.93×10颗粒/mL，96.66%±0.77%的颗粒等效圆直径小于0.5μm。磨损颗粒的长宽比为1.40（最小值：1.01；最大值：6.42）。结论：HXLPE-DG相较于常用的胫骨假体材料具有优势，并在TKA中展现出应用潜力。
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