Harris Orthopaedic Laboratory, Massachusetts General Hospital, Boston, MA.
Department of Orthopaedic Surgery, Massachusetts General Hospital, Boston, MA.
J Arthroplasty. 2023 Nov;38(11):2373-2378. doi: 10.1016/j.arth.2023.05.007. Epub 2023 May 18.
Vitamin E-diffused highly cross-linked polyethylene (VEPE) acetabular liners for total hip arthroplasty (THA) have shown favorable results in small cohort studies. However, larger studies are warranted to compare its performance to highly cross-linked polyethylene (XLPE) and demonstrate clinical significance in 10-year arthroplasty outcomes. This study compared acetabular liner wear and patient-reported outcome measures (PROMs) between patients treated with VEPE and XLPE liners in a prospective, international, multicenter study with minimum 7-year follow-up.
A total of 977 patients (17 centers; 8 countries) were enrolled from 2007 to 2012. The centers were randomly assigned to implants. At 1-year, 3-year, 5-year, and 7-year postoperative visits, radiographs, PROMs, and incidence of revision were collected. Acetabular liner wear was calculated using computer-assisted vector analysis of serial radiographs. General health, disease progression, and treatment satisfaction reported by patients were scored using 5 validated surveys and compared using Mann-Whitney U tests. At 7 years, 75.4% of eligible patients submitted data.
The mean acetabular liner wear rate was -0.009 mm/y and 0.024 mm/y for the VEPE and XLPE group, respectively (P = .01). There were no statistically significant differences in PROMs. The overall revision incidence was 1.8% (n = 18). The revision incidence in VEPE and XLPE cohorts were 1.92% (n = 10) versus 1.75% (n = 8), respectively.
We found that VEPE acetabular liners in total hip arthroplasty led to no significant clinical difference in 7-year outcomes as measured by acetabular liner wear rate, PROMs, and revision rate. While VEPE liners showed less wear, the wear rate for both the VEPE and XLPE liners was below the threshold for osteolysis. Therefore, the difference in liner wear may indicate comparative clinical performance at 7 years, as further indicated by the lack of difference in PROMs and the low revision incidence.
维生素 E 弥散的高度交联聚乙烯(VEPE)髋臼衬垫在全髋关节置换术(THA)中表现出良好的小队列研究结果。然而,需要更大的研究来比较其与高度交联聚乙烯(XLPE)的性能,并在 10 年的关节置换结果中证明其临床意义。本研究比较了在一项前瞻性、国际性、多中心研究中接受 VEPE 和 XLPE 衬垫治疗的患者的髋臼衬垫磨损和患者报告的结果测量(PROMs),随访时间至少为 7 年。
2007 年至 2012 年共纳入 977 例患者(17 个中心;8 个国家)。各中心随机分配植入物。术后 1 年、3 年、5 年和 7 年进行影像学检查、PROMs 和翻修率的收集。通过对连续影像学的计算机辅助矢量分析计算髋臼衬垫磨损。使用 5 项经过验证的调查对患者报告的一般健康状况、疾病进展和治疗满意度进行评分,并使用 Mann-Whitney U 检验进行比较。在 7 年时,75.4%的合格患者提交了数据。
VEPE 和 XLPE 组的髋臼衬垫平均磨损率分别为-0.009mm/y 和 0.024mm/y(P=.01)。PROMs 无统计学差异。总的翻修率为 1.8%(n=18)。VEPE 和 XLPE 队列的翻修率分别为 1.92%(n=10)和 1.75%(n=8)。
我们发现,在 7 年的随访中,维生素 E 弥散的高度交联聚乙烯(VEPE)髋臼衬垫在全髋关节置换术(THA)中,在髋臼衬垫磨损率、PROMs 和翻修率方面,并没有显著的临床差异。虽然 VEPE 衬垫的磨损率较低,但 VEPE 和 XLPE 衬垫的磨损率均低于溶骨性的阈值。因此,衬垫磨损的差异可能表明在 7 年时具有相当的临床性能,这进一步表明 PROMs 无差异和低翻修率。