经过退火的超高交联聚乙烯，耐磨性持续改善。
Continued improved wear with an annealed highly cross-linked polyethylene.
机构信息
Indiana University School of Medicine, 541 Clinical Drive, Suite 600, Indianapolis, IN 46202, USA.
出版信息
Clin Orthop Relat Res. 2011 Mar;469(3):825-30. doi: 10.1007/s11999-010-1556-5. Epub 2010 Sep 16.
BACKGROUND
Highly cross-linked polyethylene (HXLPE), created by disrupting the molecular structure of polyethylene, then through the application of heat, encourages creation of new cross-links in the process, resulting in a material with improved wear resistance. The impetuses for this new technology were the unsatisfactory wear properties and subsequent osteolysis of noncross-linked polyethylene. A 72% reduction in wear using highly cross-linked polyethylenes (HXLPE) compared with conventional polyethylene at 5 years was described previously. The longest term followup studies on HXLPE range from 2 to 6 years.
QUESTIONS/PURPOSES: We therefore addressed the following questions: (1) Does the improvement in wear observed at the earlier followup continue to 7 to 10 years? (2) What is the incidence of osteolysis in this group of patients and in the control group?
METHODS
We retrospectively reviewed 38 prospectively followed patients who had 42 hips with an annealed HXLPE who were followed a minimum of 7 years (average, 8.6 years; SD=1; range, 7-10.3 years). Wear and osteolysis were compared with those of a control group of 39 patients (40 hips) from a US Investigational Device Exemption (IDE) prospective, randomized study begun in 1996 with conventional polyethylene and followed for a minimum of 6 years (average, 7.5 years; SD=1.1; range, 6-10.2 years). Linear head penetration was measured from AP radiographs at early, 1-year, 5-year, and most recent followups.
RESULTS
At the average followup, annual linear wear was 0.031 mm (SD=0.014) for the HXLPE and 0.141 mm (SD=0.080) for the control group, a 78% reduction. No mechanical failure of the polyethylene was noted in either group. Incidence of osteolysis was 50% in the control group (all lesions confined to proximal Gruen Zones 1 and 7) compared with no cases in the investigational group.
CONCLUSIONS
We observed an improvement in wear and no mechanical failures with this annealed material.
LEVEL OF EVIDENCE
Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
背景
高度交联聚乙烯（HXLPE）通过破坏聚乙烯的分子结构，然后通过加热，鼓励在该过程中形成新的交联，从而产生一种具有改善耐磨性的材料。这种新技术的推动力是非交联聚乙烯的耐磨性差和随后的骨溶解。先前已经描述了在 5 年内，与传统聚乙烯相比，使用高度交联聚乙烯（HXLPE）可将磨损减少 72%。关于 HXLPE 的最长随访研究时间范围为 2 至 6 年。
问题/目的：因此，我们提出了以下问题：（1）在早期随访中观察到的磨损改善是否持续到 7 至 10 年？（2）在该组患者和对照组中，骨溶解的发生率是多少？
方法
我们回顾性分析了 38 例前瞻性随访的患者，这些患者共有 42 髋接受了退火 HXLPE，随访时间至少为 7 年（平均 8.6 年；SD=1；范围 7-10.3 年）。与 1996 年开始的美国研究性设备豁免（IDE）前瞻性、随机研究中使用传统聚乙烯的对照组的 39 例患者（40 髋）进行比较，对照组随访时间至少为 6 年（平均 7.5 年；SD=1.1；范围 6-10.2 年）。使用前后位 X 线片测量早期、1 年、5 年和最近随访时的线性头部穿透。
结果
在平均随访时，HXLPE 的年线性磨损为 0.031mm（SD=0.014），对照组为 0.141mm（SD=0.080），减少了 78%。两组均未发现聚乙烯的机械故障。对照组的骨溶解发生率为 50%（所有病变均局限于近端 Gruen 区 1 和 7），而研究组无病例。
结论
我们观察到这种退火材料在磨损方面有所改善，且无机械故障。
证据水平
III 级，治疗性研究。有关证据水平的完整描述，请参见作者指南。
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