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维生素 E 共混的超高交联聚乙烯衬垫在全髋关节置换术中的应用:一项使用基于虚拟 CAD 的磨损分析的 5 年随访、随机、多中心研究。

Vitamin E-blended highly cross-linked polyethylene liners in total hip arthroplasty: a randomized, multicenter trial using virtual CAD-based wear analysis at 5-year follow-up.

机构信息

Department of Orthopaedics, Trauma and Reconstructive Surgery Marienhospital Mülheim an der Ruhr, Chair of Orthopaedics and Trauma Surgery University of Duisburg-Essen, Essen, Germany.

Institut für Medizintechnik und Forschungscampus STIMULATE, Otto-von-Guericke-Universität Magdeburg, Magdeburg, Germany.

出版信息

Arch Orthop Trauma Surg. 2020 Dec;140(12):1859-1866. doi: 10.1007/s00402-020-03358-x. Epub 2020 Feb 12.

Abstract

BACKGROUND

Progressive oxidation of highly cross-linked ultra-high molecular weight (UHMPWE-X) liners is considered to be a risk factor for material failure in THA. Antioxidants such as vitamin E (alpha-tocopherol) (UHMWPE-XE) were supplemented into the latest generation of polyethylene liners. To prevent inhomogenous vitamin E distribution within the polymer, blending was established as an alternative manufacturing process to diffusion. The purpose of the present study was to investigate the in vivo wear behavior of UHMWPE-XE in comparison with conventional UHMWPE-X liners using virtual CAD-based radiographs.

METHODS

Until now, 94 patients from a prospective, randomized, controlled, multicenter study were reviewed at 5-year follow-up. Of these, 51 (54%) received UHMWPE-XE and 43 (46%) UHMWPE-X liners. Anteroposterior pelvic radiographs were made immediately after surgery and at 1 and 5 years postoperatively. The radiographs were analyzed using the observer-independent analysis software RayMatch (Raylytic GmbH, Leipzig, Germany).

RESULTS

The mean wear rate was measured to be 23.6 μm/year (SD 13.7; range 0.7-71.8 μm). There were no significant differences between the two cohorts (UHMWPE-X: 23.2 μm/year vs. UHMWPE-XE: 24.0 μm/year, p = 0.73). Cup anteversion significantly changed within the 1st year after implantation independent from the type of polyethylene liner [UHMWPE-X: 18.2-23.9° (p = 0.0001); UHMWPE-XE: 21.0-25.5° (p = 0.002)]. No further significant changes of cup anteversion in both groups were found between year 1 and 5 after implantation [UHMWPE-X (p = 0.46); UHMWPE-XE (p = 0.56)].

CONCLUSION

The present study demonstrates that the addition of vitamin E does not adversely affect the midterm wear behavior of UHMWPE-X. The antioxidative benefit of vitamin E is expected to become evident in long-term follow-up. Cup anteversion increment by 5° within the 1st year is likely a result of the released hip flexion contracture resulting in an enhanced posterior pelvic tilt. Therefore, a reassessment of target values in acetabular cup placement might be considered.

摘要

背景

高度交联超高分子量(UHMWPE)衬垫的渐进氧化被认为是 THA 中材料失效的一个风险因素。抗氧化剂,如维生素 E(α-生育酚)(UHMWPE-XE)被添加到最新一代的聚乙烯衬垫中。为了防止聚合物内维生素 E 分布不均匀,混合被确立为扩散的替代制造工艺。本研究的目的是使用基于虚拟 CAD 的射线照相术,比较 UHMWPE-XE 与传统 UHMWPE-X 衬垫的体内磨损行为。

方法

直到现在,在 5 年的随访中,对来自一项前瞻性、随机、对照、多中心研究的 94 名患者进行了回顾。其中,51 名(54%)接受了 UHMWPE-XE 衬垫,43 名(46%)接受了 UHMWPE-X 衬垫。在手术后立即以及术后 1 年和 5 年进行前后骨盆射线照相。使用独立于观察者的分析软件 RayMatch(Raylytic GmbH,莱比锡,德国)对射线照片进行分析。

结果

测量的平均磨损率为 23.6μm/年(标准差 13.7;范围 0.7-71.8μm)。两组之间没有显著差异(UHMWPE-X:23.2μm/年与 UHMWPE-XE:24.0μm/年,p=0.73)。杯倾斜角在植入后 1 年内显著变化,与聚乙烯衬垫类型无关[UHMWPE-X:18.2-23.9°(p=0.0001);UHMWPE-XE:21.0-25.5°(p=0.002)]。在植入后 1 年至 5 年期间,两组均未发现杯倾斜角的进一步显著变化[UHMWPE-X(p=0.46);UHMWPE-XE(p=0.56)]。

结论

本研究表明,添加维生素 E 不会对 UHMWPE-X 的中期磨损行为产生不利影响。维生素 E 的抗氧化益处预计在长期随访中显现出来。植入后 1 年内增加 5°的杯倾斜角可能是由于释放的髋关节屈曲挛缩导致后骨盆倾斜增加所致。因此,可能需要重新考虑髋臼杯放置的目标值。

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