高度交联聚乙烯降低全髋关节置换术的磨损和翻修率：一项10年双盲随机对照试验
Highly Cross-Linked Polyethylene Reduces Wear and Revision Rates in Total Hip Arthroplasty: A 10-Year Double-Blinded Randomized Controlled Trial.
作者信息
Devane Peter A, Horne James Geoffrey, Ashmore Alexander, Mutimer Jonathon, Kim Woosung, Stanley James
机构信息
1Wellington Hospital, Wellington, New Zealand 2Great Western Hospital, Swindon, United Kingdom 3Cheltenham General Hospital, Cheltenham, United Kingdom 4University of Otago, Wellington, New Zealand.
出版信息
J Bone Joint Surg Am. 2017 Oct 18;99(20):1703-1714. doi: 10.2106/JBJS.16.00878.
BACKGROUND
Highly cross-linked polyethylene (XLPE) was developed to address the problem of wear and osteolysis associated with metal-on-conventional ultra-high molecular weight polyethylene (UHMWPE) bearing surfaces. The purpose of this study was to compare in vivo wear rates and clinical and radiographic outcomes between XLPE and UHMWPE in a prospective double-blinded randomized controlled trial with a minimum of 10 years of follow-up.
METHODS
We randomized 122 patients to receive either a conventional UHMWPE liner (Enduron; DePuy) or an XLPE liner (Marathon; DePuy). Ninety-one patients were assessed clinically and radiographically at a minimum of 10 years (range, 10.08 to 12.17 years). Oxford Hip Scores and Short Form-12 Health Survey scores were collected. The radiographs were analyzed for osteolysis and for 2-dimensional (2-D), 3-dimensional (3-D), and volumetric wear using validated software.
RESULTS
All 122 patients were accounted for at the 10-year follow-up evaluation. Twelve patients had undergone revision surgery, 21 patients had died (1 of whom had previously undergone revision surgery), and 2 patients were unable to return for follow-up, leaving 91 patients available for clinical and radiographic evaluation. At a minimum of 10 years, 3-D wear rates were significantly lower (p < 0.001) in the XLPE group (mean, 0.03 mm/yr) than in the conventional UHMWPE group (mean, 0.27 mm/yr). The prevalence of osteolysis was also significantly lower in the XLPE group (38% versus 8%, p < 0.005), as was the revision rate (14.6% versus 1.9%, p = 0.012), with 10 of the 12 revisions being in the Enduron group. There was no significant difference between the clinical scores of the 2 groups.
CONCLUSIONS
XLPE liners have significantly reduced wear and are associated with a greater implant survival rate at 10 years compared with conventional UHMWPE liners.
LEVEL OF EVIDENCE
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
背景
高度交联聚乙烯（XLPE）的研发旨在解决与金属对传统超高分子量聚乙烯（UHMWPE）关节面相关的磨损和骨溶解问题。本研究的目的是在一项前瞻性双盲随机对照试验中，比较XLPE和UHMWPE的体内磨损率以及临床和影像学结果，随访时间至少为10年。
方法
我们将122例患者随机分为两组，分别接受传统UHMWPE衬垫（Enduron；DePuy）或XLPE衬垫（Marathon；DePuy）。对91例患者进行了至少10年（范围为10.08至12.17年）的临床和影像学评估。收集牛津髋关节评分和简短健康调查问卷12项评分。使用经过验证的软件对X线片进行骨溶解分析以及二维（2-D）、三维（3-D）和体积磨损分析。
结果
在10年随访评估中，所有122例患者均有记录。12例患者接受了翻修手术，21例患者死亡（其中1例曾接受翻修手术），2例患者无法返回进行随访，剩余91例患者可进行临床和影像学评估。至少10年时，XLPE组的三维磨损率（平均0.03 mm/年）显著低于传统UHMWPE组（平均0.27 mm/年）（p < 0.001）。XLPE组的骨溶解患病率也显著较低（38%对8%，p < 0.005），翻修率同样较低（14.6%对1.9%，p = 0.012），12例翻修中有10例在Enduron组。两组的临床评分无显著差异。
结论
与传统UHMWPE衬垫相比，XLPE衬垫显著降低了磨损，并在10年时具有更高的植入物生存率。
证据水平
治疗性I级。有关证据水平的完整描述，请参阅作者指南。
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