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翻修的高度交联聚乙烯全膝关节置换术胫骨假体衬垫的交联密度降低且氧化增加。

Crosslink Density Is Reduced and Oxidation Is Increased in Retrieved Highly Crosslinked Polyethylene TKA Tibial Inserts.

作者信息

Liu Tong, Esposito Christina I, Burket Jayme C, Wright Timothy M

机构信息

Department of Biomechanics, Hospital for Special Surgery, 535 East 70th Street, New York, NY, 10021, USA.

Department of Orthopaedics, China-Japan Union Hospital of Jilin University, Changchun, Jilin, China.

出版信息

Clin Orthop Relat Res. 2017 Jan;475(1):128-136. doi: 10.1007/s11999-016-4820-5.

Abstract

BACKGROUND

The wear resistance of highly crosslinked polyethylene depends on crosslink density, which may decrease with in vivo loading, leading to more wear and increased oxidation. The relationship among large and complex in vivo mechanical stresses, breakdown of the polyethylene crosslinks, and oxidative degradation is not fully understood in total knee arthroplasty (TKA). We wished to determine whether crosslink density is reduced at the articular surfaces of retrieved tibial inserts in contact areas exposed to in vivo mechanical stress.

QUESTIONS/PURPOSES: (1) Does polyethylene crosslink density decrease preferentially in regions of the articular surface of thermally stabilized crosslinked polyethylene tibial components exposed to mechanical stress in vivo; and (2) what is the ramification of decreased crosslink density in TKA in terms of accompanying oxidation of the polyethylene?

METHODS

From May 2011 to January 2014, 90 crosslinked polyethylene tibial components were retrieved during revision surgery as a part of a long-standing implant retrieval program. Forty highly crosslinked polyethylene tibial inserts (27 posterior-stabilized designs and 13 cruciate-retaining designs) retrieved for instability (15 cases), stiffness (11), infection (six), aseptic loosening (four), pain (two), and malposition (two) after a mean time of 18 months were inspected microscopically to identify loaded (burnished) and unloaded (unburnished) regions on the articular surfaces. Swell ratio testing was done according to ASTM F2214 to calculate crosslink density and infrared spectroscopy was used according to ASTM F2102 to measure oxidation.

RESULTS

The region of the tibial insert influenced crosslink density. Loaded surface regions had a mean crosslink density of 0.19 (95% confidence interval [CI], 0.18-0.19) mol/dm, lower than the other three regions (loaded subsurface, unloaded surface, and unloaded subsurface), which had crosslink densities of 0.21 (95% CI, 0.21-0.22; p < 0.01) mol/dm. Peak oxidation levels were higher in loaded regions with a mean oxidation index (OI) of 0.67 (95% CI, 0.56-0.78) versus unloaded regions with a mean OI of 0.36 (95% CI, 0.27-0.45; p < 0.01). Peak oxidation levels were higher in annealed samples with a mean OI of 0.66 (95% CI, 0.52-0.81) versus remelted samples with a mean OI of 0.40 (95% CI, 0.34-0.47; p < 0.01).

CONCLUSIONS

The results suggest that the crosslink density decreases and accompanying oxidation is driven predominantly by contact stress conditions. If crosslink density continues to decrease with continued loading over time, crosslinked polyethylene may not provide a clinical advantage over conventional polyethylene in the long term for TKA. Therefore, we will continue to collect longer term retrievals to evaluate mechanical property changes in crosslinked polyethylenes.

CLINICAL RELEVANCE

Although we found a decrease in crosslink density and increase in oxidation in the tibial inserts, the degree of oxidation does not suggest, for now, a reason for concern in these early retrievals. The OI values of the tibial inserts in this study were lower than the critical oxidation level (OI > 3) reported in the literature where polyethylene may lose mechanical properties and have the compromised ability to withstand mechanical loading.

摘要

背景

高度交联聚乙烯的耐磨性取决于交联密度,而交联密度可能会随着体内负荷而降低,从而导致更多磨损和氧化增加。在全膝关节置换术(TKA)中,体内复杂的大机械应力、聚乙烯交联键的断裂和氧化降解之间的关系尚未完全明确。我们希望确定在取出的胫骨假体接触区域的关节表面,暴露于体内机械应力下时交联密度是否降低。

问题/目的:(1)在体内暴露于机械应力的热稳定交联聚乙烯胫骨部件的关节表面区域,聚乙烯交联密度是否优先降低;(2)就聚乙烯伴随的氧化而言,TKA中交联密度降低的后果是什么?

方法

从2011年5月至2014年1月,作为一项长期植入物取出计划的一部分,在翻修手术中取出90个交联聚乙烯胫骨部件。对40个高度交联聚乙烯胫骨假体(27个后稳定型设计和13个十字韧带保留型设计)进行检查,这些假体在平均18个月后因不稳定(15例)、僵硬(11例)、感染(6例)、无菌性松动(4例)、疼痛(2例)和位置异常(2例)而被取出,通过显微镜检查确定关节表面的负荷(抛光)和未负荷(未抛光)区域。根据ASTM F2214进行溶胀率测试以计算交联密度,并根据ASTM F2102使用红外光谱法测量氧化程度。

结果

胫骨假体区域影响交联密度。负荷表面区域的平均交联密度为0.19(95%置信区间[CI],0.18 - 0.19)mol/dm,低于其他三个区域(负荷次表面、未负荷表面和未负荷次表面),其交联密度为0.21(95% CI,0.21 - 0.22;p < 0.01)mol/dm。负荷区域的峰值氧化水平更高,平均氧化指数(OI)为0.67(95% CI,0.56 - 0.78),而未负荷区域的平均OI为0.36(95% CI,0.27 - 0.45;p < 0.01)。退火样品的峰值氧化水平更高,平均OI为0.66(95% CI,0.52 - 0.81),而重熔样品的平均OI为0.40(95% CI,0.34 - 0.47;p < 0.01)。

结论

结果表明交联密度降低且伴随的氧化主要由接触应力条件驱动。如果随着时间的推移持续负荷导致交联密度继续降低,从长期来看,交联聚乙烯在TKA中可能不会比传统聚乙烯具有临床优势。因此,我们将继续收集长期取出的样本以评估交联聚乙烯的力学性能变化。

临床意义

尽管我们发现胫骨假体的交联密度降低且氧化增加,但目前这些早期取出样本中的氧化程度尚无令人担忧的理由。本研究中胫骨假体的OI值低于文献报道的临界氧化水平(OI > 3),在该水平下聚乙烯可能会失去力学性能并降低承受机械负荷的能力。

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