Background 

Highly cross-linked polyethylene (HXLPE) can improve wear properties in TKA, but it can also lead to decreased mechanical properties. Antioxidants were added to HXLPE to improve its mechanical properties while retaining the improved wear characteristics. However, it remains unclear whether these modifications to conventional polytheylene used in TKA have resulted in a change in the revision risk.

Questions/purposes 

We used American Joint Replacement Registry data to ask: (1) Is there a difference in all-cause revision in patients who underwent TKA using HXLPE with or without an antioxidant doping compared with conventional polyethylene? (2) Is there a difference in revision for aseptic failure in patients who underwent TKA using HXLPE with or without an antioxidant doping compared with conventional polyethylene?

Methods 

We analyzed American Joint Replacement Registry data from 2012 to 2019. We identified 339,366 primary TKAs over the study period in patients older than 65 years and linked procedures to supplemental Centers for Medicare & Medicaid data where available. Patient total number of reported comorbidities, gender, age, region, polyethylene characteristics, procedure dates, and indication for revision were recorded. Median follow-up was 34 months. We compared HXLPE with or without antioxidants to conventional polyethylene. Event-free percent survival curves and Cox proportional hazard regression modeling was used for all-cause revision and revision for aseptic failure.

Results 

Compared with conventional polyethylene, there was no difference in all-cause revision with HXLPE with an antioxidant (HR 1.06 [95% CI 0.98 to 1.14]; p = 0.13) or HXLPE without an antioxidant (HR 1.04 [95% CI 0.97 to 1.11]; p = 0.28). Compared with conventional polyethylene, there was no difference in revision for aseptic failure with HXLPE with an antioxidant (HR 1.07 [95% CI 0.99 to 1.14]; p = 0.08) or HXLPE without an antioxidant (HR 1.03 [95% CI 0.97 to 1.01]; p = 0.30).

Conclusion 

We found no difference in revision risk between HXLPE with or without an antioxidant and conventional polyethylene during this time frame. HXLPE polyethylene, with or without an antioxidant, should not be widely adopted until or unless it is shown to be superior to conventional polyethylene in TKA.

Level of Evidence 

Level III, therapeutic study.

中文翻译：

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与传统聚乙烯相比，在 TKA 中使用或不使用抗氧化剂的高度交联聚乙烯相关的翻修风险没有降低：来自美国关节置换登记处的分析

背景 

高交联聚乙烯 (HXLPE) 可以改善 TKA 的耐磨性能，但也会导致机械性能下降。向 HXLPE 中添加抗氧化剂以改善其机械性能，同时保留改善的耐磨特性。然而，目前尚不清楚这些对 TKA 中使用的传统聚乙烯的修改是否会导致翻修风险发生变化。

问题/目的 

我们使用美国关节置换登记处的数据来询问：(1) 与传统聚乙烯相比，使用添加或不添加抗氧化剂的 HXLPE 进行 TKA 的患者在全因翻修方面是否存在差异？(2) 与传统聚乙烯相比，使用添加或不添加抗氧化剂的 HXLPE 进行 TKA 的患者在无菌失败翻修方面是否存在差异？

方法 

我们分析了 2012 年至 2019 年美国关节置换登记处的数据。我们在研究期间确定了 65 岁以上患者的 339,366 例初次全膝关节置换术，并将程序与可用的医疗保险和医疗补助数据补充中心相关联。记录报告合并症的患者总数、性别、年龄、地区、聚乙烯特性、手术日期和翻修指征。中位随访时间为 34 个月。我们将添加或不添加抗氧化剂的 HXLPE 与传统聚乙烯进行了比较。无事件百分比生存曲线和 Cox 比例风险回归模型用于全因修正和无菌失败修正。

结果 

与传统聚乙烯相比，含抗氧化剂的 HXLPE (HR 1.06 [95% CI 0.98 至 1.14]；p = 0.13) 或不含抗氧化剂的 HXLPE (HR 1.04 [95% CI 0.97 至 1.11) 在全因修正方面没有差异]；p = 0.28）。与传统聚乙烯相比，使用含抗氧化剂的 HXLPE (HR 1.07 [95% CI 0.99 至 1.14]；p = 0.08) 或不含抗氧化剂的 HXLPE (HR 1.03 [95% CI 0.97 至 1.01) 无菌失败的翻修率没有差异]；p = 0.30）。

结论 

我们发现在此时间范围内，含或不含抗氧化剂的 HXLPE 与传统聚乙烯的翻修风险没有差异。含或不含抗氧化剂的 HXLPE 聚乙烯不应被广泛采用，直到或除非它在 ​​TKA 中被证明优于传统聚乙烯。

证据等级 

III 级，治疗研究。