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氧化锆陶瓷模块化股骨头在骨水泥型全髋关节置换术中五年内并不能减少聚乙烯磨损:一项对120例髋关节进行放射立体测量分析的随机试验。

Oxinium modular femoral heads do not reduce polyethylene wear in cemented total hip arthroplasty at five years: a randomised trial of 120 hips using radiostereometric analysis.

作者信息

Jonsson B A, Kadar T, Havelin L I, Haugan K, Espehaug B, Indrekvam K, Furnes O, Hallan G

机构信息

Haukeland University Hospital, Bergen, Norway.

Trondheim University Hospital, Trondheim, Norway.

出版信息

Bone Joint J. 2015 Nov;97-B(11):1463-9. doi: 10.1302/0301-620X.97B11.36137.

DOI:10.1302/0301-620X.97B11.36137
PMID:26530646
Abstract

We report the five-year outcome of a randomised controlled trial which used radiostereometric analysis (RSA) to assess the influence of surface oxidised zirconium (OxZr, Oxinium) on polyethylene wear in vivo. A total of 120 patients, 85 women and 35 men with a mean age of 70 years (59 to 80) who were scheduled for primary cemented total hip arthroplasty were randomly allocated to four study groups. Patients were blinded to their group assignment and received either a conventional polyethylene (CPE) or a highly cross-linked (HXL) acetabular component of identical design. On the femoral side patients received a 28 mm head made of either cobalt-chromium (CoCr) or OxZr. The proximal head penetration (wear) was measured with repeated RSA examinations over five years. Clinical outcome was measured using the Harris hip score. There was no difference in polyethylene wear between the two head materials when used with either of the two types of acetabular component (p = 0.3 to 0.6). When comparing the two types of polyethylene there was a significant difference in favour of HXLPE, regardless of the head material used (p < 0.001). In conclusion, we found no advantage of OxZr over CoCr in terms of polyethylene wear after five years of follow-up. Our findings do not support laboratory results which have shown a reduced rate of wear with OxZr. They do however add to the evidence on the better resistance to wear of HXLPE over CPE.

摘要

我们报告了一项随机对照试验的五年结果,该试验使用放射性立体测量分析(RSA)来评估表面氧化锆(OxZr,奥新金属)对体内聚乙烯磨损的影响。共有120例患者,85名女性和35名男性,平均年龄70岁(59至80岁),计划进行初次骨水泥型全髋关节置换术,被随机分配到四个研究组。患者对其分组情况不知情,接受了设计相同的传统聚乙烯(CPE)或高度交联(HXL)髋臼组件。在股骨侧,患者接受了由钴铬合金(CoCr)或OxZr制成的28毫米股骨头。通过五年内重复的RSA检查测量近端股骨头的穿透情况(磨损)。使用Harris髋关节评分评估临床结果。当与两种类型的髋臼组件中的任何一种一起使用时,两种股骨头材料之间的聚乙烯磨损没有差异(p = 0.3至0.6)。当比较两种类型的聚乙烯时,无论使用何种股骨头材料,都存在有利于HXLPE的显著差异(p < 0.001)。总之,在随访五年后,我们发现在聚乙烯磨损方面,OxZr并不比CoCr更具优势。我们的研究结果不支持实验室结果,实验室结果显示OxZr的磨损率较低。然而,它们确实增加了关于HXLPE比CPE更耐磨的证据。

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