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Oxidized zirconium versus cobalt-chrome femoral heads in total hip arthroplasty: a multicentre prospective randomized controlled trial with ten years' follow-up.
The Bone & Joint Journal ( IF 4.9 ) Pub Date : 2022-07-01 , DOI: 10.1302/0301-620x.104b7.bjj-2021-1673.r1
Babar Kayani 1 , Joanna Baawa-Ameyaw 1 , Andreas Fontalis 1 , Jenni Tahmassebi 1 , Nick Wardle 2 , Robert Middleton 3 , Arthur Stephen 4 , James Hutchinson 4 , Fares S Haddad 1
Affiliation  

AIMS This study reports the ten-year wear rates, incidence of osteolysis, clinical outcomes, and complications of a multicentre randomized controlled trial comparing oxidized zirconium (OxZr) versus cobalt-chrome (CoCr) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) and highly cross-linked polyethylene (XLPE) liners in total hip arthroplasty (THA). METHODS Patients undergoing primary THA were recruited from four institutions and prospectively allocated to the following treatment groups: Group A, CoCr femoral head with XLPE liner; Group B, OxZr femoral head with XLPE liner; and Group C, OxZr femoral head with UHMWPE liner. All study patients and assessors recording outcomes were blinded to the treatment groups. The outcomes of 262 study patients were analyzed at ten years' follow-up. RESULTS Patients in Group C were associated with increased mean liner wear rates compared to patients in Group A (0.133 mm/yr (SD 0.21) vs 0.031 mm/yr (SD 0.07), respectively; p < 0.001) and Group B (0.133 mm/yr (SD 0.21) vs 0.022 mm/yr (SD 0.05), respectively; p < 0.001) at ten years' follow-up. Patients in Group C were also associated with increased risk of osteolysis and aseptic loosening requiring revision surgery, compared with patients in Group A (7/133 vs 0/133, respectively; p = 0.007) and Group B (7/133 vs 0/135, respectively; p = 0.007). There was a non-statistically significant trend towards increased mean liner wear rates in Group A compared with Group B (0.031 mm/yr (SD 0.07) vs 0.022 mm/yr (SD 0.05), respectively; p = 0.128). All three groups were statistically comparable preoperatively and at ten years' follow-up when measuring normalized Western Ontario and McMaster Universities Osteoarthritis Index (p = 0.410), 36-Item Short Form Health Survey (p = 0.465 mental, p = 0.713 physical), and pain scale scores (p = 0.451). CONCLUSION The use of UHMWPE was associated with progressively increased annual liner wear rates after THA compared to XLPE. At ten years' follow-up, the group receiving UHMWPE demonstrated an increased incidence of osteolysis and aseptic loosening requiring revision surgery compared to XLPE. Femoral heads composed of OxZr were associated with trend towards reduced wear rates compared to CoCr, but this did not reach statistical significance and did not translate to any differences in osteolysis, functional outcomes, or revision surgery between the two femoral head components. Cite this article: Bone Joint J 2022;104-B(7):833-843.

中文翻译:

全髋关节置换术中氧化锆与钴铬股骨头的对比:一项为期十年的多中心前瞻性随机对照试验。

目的 本研究报告了一项多中心随机对照试验,比较氧化锆 (OxZr) 与钴铬 (CoCr) 股骨头与超高分子量聚乙烯 (UHMWPE) 的十年磨损率、骨溶解发生率、临床结果和并发症) 和全髋关节置换术 (THA) 中的高度交联聚乙烯 (XLPE) 衬垫。方法 从四家机构招募接受初次 THA 的患者,并前瞻性分配到以下治疗组:A 组,CoCr 股骨头加 XLPE 内衬;B 组,带 XLPE 衬垫的 OxZr 股骨头;和 C 组,带 UHMWPE 衬垫的 OxZr 股骨头。所有记录结果的研究患者和评估者都对治疗组不知情。在十年的随访中分析了 262 名研究患者的结果。结果 与 A 组(分别为 0.133 mm/yr (SD 0.21) vs 0.031 mm/yr (SD 0.07);p < 0.001)和 B 组(0.133 mm)患者相比,C 组患者的平均衬垫磨损率增加。 /yr (SD 0.21) 与 0.022 mm/yr (SD 0.05) 分别;p < 0.001) 在十年的随访中。与 A 组(分别为 7/133 对 0/133;p = 0.007)和 B 组(7/133 对 0/ 135,分别;p = 0.007)。与 B 组相比,A 组的平均衬板磨损率增加(分别为 0.031 毫米/年 (SD 0.07) 和 0.022 毫米/年 (SD 0.05);p = 0.128),存在非统计显着趋势。所有三组在术前和十年时具有统计学可比性 测量标准化西安大略和麦克马斯特大学骨关节炎指数(p = 0.410)、36 项简短健康调查(p = 0.465 心理,p = 0.713 身体)和疼痛量表评分(p = 0.451)时的随访。结论 与 XLPE 相比,在 THA 后使用 UHMWPE 与逐渐增加的年衬里磨损率有关。在十年的随访中,与 XLPE 相比,接受 UHMWPE 组的骨质溶解和无菌性松动需要翻修手术的发生率增加。与 CoCr 相比,由 OxZr 组成的股骨头与磨损率降低的趋势相关,但这没有达到统计学意义,也没有转化为两个股骨头部件之间的骨质溶解、功能结果或翻修手术的任何差异。引用这篇文章:骨关节 J 2022;104-B(7):
更新日期:2022-07-01
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