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Clin Orthop Relat Res. 2011 Aug;469(8):2262-77. doi: 10.1007/s11999-011-1872-4.
Highly crosslinked polyethylene (HXLPE) was introduced to reduce wear and osteolysis in total joint arthroplasty. While many studies report wear and osteolysis associated with HXLPE, analytical techniques, clinical study design and followup, HXLPE formulation and implant design characteristics, and patient populations differ substantially among investigations, complicating a unified perspective.
QUESTIONS/PURPOSES: Literature on first-generation HXLPE was summarized. We systematically reviewed the radiographic wear data and incidence of osteolysis for HXLPE in hip and knee arthroplasty.
PubMed identified 391 studies; 28 met inclusion criteria for a weighted-averages analysis of two-dimensional femoral head penetration rates. To determine the incidence of osteolysis, we estimated a pooled odds ratio using a random-effects model.
Weighted-averages analyses of femoral head penetration rates in HXLPE liners and conventional UHMWPE liners resulted, respectively, in a mean two-dimensional linear penetration rate of 0.042 mm/year based on 28 studies (n=1503 hips) and 0.137 mm/year based on 18 studies (n=695 hips). The pooled odds ratio for the risk of osteolysis in HXLPE versus conventional liners was 0.13 (95% confidence interval, 0.06-0.27) among studies with minimum 5-year followup. We identified two clinical studies of HXLPE in TKA, preventing systematic analysis of outcomes.
HXLPE liner studies consistently report lower femoral head penetration and an 87% lower risk of osteolysis. Reduction in femoral head penetration or osteolysis risk is not established for large-diameter (>32 mm) metallic femoral heads or ceramic femoral heads of any size. Few studies document the clinical performance of HXLPE in knees.
高度交联聚乙烯(HXLPE)的引入是为了减少全关节置换术中的磨损和骨溶解。虽然许多研究报告了与 HXLPE 相关的磨损和骨溶解,但分析技术、临床研究设计和随访、HXLPE 配方和植入物设计特点以及患者人群在研究中存在很大差异,这使得难以形成统一的观点。
问题/目的:总结第一代 HXLPE 的文献。我们系统地回顾了髋关节和膝关节置换术中 HXLPE 的放射学磨损数据和骨溶解发生率。
通过 PubMed 确定了 391 项研究;28 项符合纳入标准,可进行二维股骨头穿透率的加权平均值分析。为了确定骨溶解的发生率,我们使用随机效应模型估计了合并的优势比。
基于 28 项研究(n=1503 髋),HXLPE 衬里和传统超高分子量聚乙烯衬里的股骨头穿透率加权平均值分析分别得出二维线性穿透率的平均值为 0.042mm/年,基于 18 项研究(n=695 髋)的结果为 0.137mm/年。在随访时间至少为 5 年的研究中,HXLPE 与传统衬里相比,骨溶解风险的合并优势比为 0.13(95%置信区间,0.06-0.27)。我们发现了两项关于 TKA 中 HXLPE 的临床研究,这使得无法对结果进行系统分析。
HXLPE 衬里研究一致报告股骨头穿透率较低,骨溶解风险降低 87%。对于大直径(>32mm)金属股骨头或任何尺寸的陶瓷股骨头,股骨头穿透率或骨溶解风险的降低尚未得到证实。很少有研究记录 HXLPE 在膝关节中的临床性能。