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对于65岁以下男性,伯明翰髋关节表面置换术的生存率是否优于某些传统髋关节置换术?来自澳大利亚骨科协会国家关节置换登记处的一项研究。

Is the Survivorship of Birmingham Hip Resurfacing Better Than Selected Conventional Hip Arthroplasties in Men Younger Than 65 Years of Age? A Study from the Australian Orthopaedic Association National Joint Replacement Registry.

作者信息

Stoney James, Graves Stephen E, de Steiger Richard N, Rainbird Sophia, Kelly Thu-Lan, Hatton Alesha

机构信息

J. Stoney, S. E. Graves, R. N. de Steiger, S. Rainbird, Australian Orthopaedic Association National Joint Replacement Registry, South Australian Health and Medical Research Institute, Adelaide, Australia.

S. E. Graves, UniSA Clinical & Health Sciences, University of South Australia, Adelaide, Australia.

出版信息

Clin Orthop Relat Res. 2020 Nov;478(11):2625-2636. doi: 10.1097/CORR.0000000000001453.

Abstract

BACKGROUND

The Birmingham Hip Resurfacing (BHR) prosthesis is the most commonly used metal-on-metal hip resurfacing arthroplasty device. The current manufacturer-recommended target demographic for the BHR is male patients, younger than 65 years requiring a femoral head size of ≥ 50 mm. Female patients, older patients, and individuals with smaller femoral-head diameter (≤ 50 mm) are known to have higher revision rates. Prior studies suggest that the survivorship of the BHR when used in the target demographic is comparable with that of primary conventional THA, but comparing survivorship of the most durable hip resurfacing arthroplasty device to the survivorship of all conventional THA prostheses is not ideal because the THA group comprises a large number of different types of prostheses that have considerable variation in prosthesis survival. A more informative comparison would be with the THA implants with the best survivorship, as this might help address the question of whether survivorship in the BHR target population can be improved by using a well-performing conventional THA.

QUESTIONS/PURPOSES: We compared the difference in cumulative percent revision, reasons for revision and types of revision for procedures reported to the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) using the BHR prosthesis (femoral-head size > 50 mm) and three conventional THA prostheses identified as having the lowest 10-year cumulative percent revision in the currently recommended BHR target population to ask: (1) Does the BHR have a lower cumulative revision rate than the group of three conventional THA prostheses? (2) Is there a difference in the revision diagnosis between the BHR and the three best conventional THA prostheses? (3) What is the difference in the components used for a revision of a BHR compared with the three best conventional THA prostheses?

METHODS

Data reported to the AOANJRR between September 1, 1999 and December 31, 2018 was used for this analysis. This study period includes almost the entire use of the BHR in Australia. The AOANJRR is a large national joint registry with almost 100% completeness, high accuracy, rigorous validation, and little to no loss to follow-up. The study population included males younger than 65 years that had received one hip replacement procedure for osteoarthritis. All patients with bilateral procedures, no matter the time interval between hips, were excluded. Only BHR prostheses with a femoral-head size ≥ 50 mm and conventional THA prostheses with femoral head sizes ≥ 32 mm and either ceramic-on-ceramic or metal, ceramic, ceramicized metal-on-crosslinked polyethylene (XLPE) bearings were included. These femoral head sizes and bearings were selected because they reflect modern conventional THA practice. There is no difference in the revision rate of these bearings in the AOANJRR. There were 4790 BHR procedures and 2696 conventional THA procedures in the study group. The mean (± SD) age for BHR procedures was 52 ± 7.8 years and 56 ± 7.1 years for conventional THA procedures. All comparative analyses were adjusted for age. Other demographics data including American Society Anesthesiologists (ASA) score and BMI were only included in AOANJRR data collection since 2012 and 2015, respectively, and have not been included in this analysis because of the low use of BHR in Australia since that time. The maximum follow-up was 18.7 years for both groups and mean follow-up of 11.9 years for the BHR and 9.3 years for the conventional THA group. Revision rates were determined using Kaplan-Meier estimates of survivorship to describe the time to the first revision, with censoring at the time of death or closure of the database at the time of analysis. A revision was defined as removal, replacement or addition of any component of a joint replacement. Revisions can be further classified as major revisions (removal of a component articulating with bone-usually the stem and/or the shell) or minor revisions (removal of other components-usually the head and/or the liner). The unadjusted cumulative percent revision after the primary arthroplasty (with 95% confidence intervals) was calculated and compared using Cox proportional hazard models adjusted for age.

RESULTS

The BHR prosthesis had a statistically higher rate of all-cause revision at 17 years than the selected conventional THA prostheses (HR 2.77 [95% CI 1.78 to 4.32]; p < 0.001). The revision diagnoses differed between the groups, with the BHR demonstrating a higher revision rate for loosening after 2 years than the conventional THA protheses (HR 4.64 [95% CI 1.66 to 12.97]; p = 0.003), as well as a higher fracture rate during the entire period (HR 2.57 [95% CI 1.24 to 5.33]; p = 0.01). There was a lower revision rate for infection for the BHR compared with the THA group in the first 5 years, with no difference between the two groups after this time. All revisions of the BHR were major revisions (such as, removal or exchange of the femoral and/or acetabular components) and this occurred in 4.5% of the primary BHR procedures. Major revision was the most common type of revision for primary THA accounting for 1.7% of all primary THA procedures. Minor revisions (head, inset or both) were undertaken in a further 0.6% of primary THA procedures.

CONCLUSIONS

Given the increasing revision risk of the BHR compared with better-performing conventional THA prostheses in the target population, we recommend that patients be counseled about this risk. We suggest that a THA with proven low revision rates might be the better choice, particularly for patients who are concerned about implant durability. Well-controlled prospective studies that show appreciable clinically important differences in patient-reported outcomes and functional results favoring the BHR over conventional THA prostheses using modern bearings are needed to justify the use of the BHR in view of this revision risk.

LEVEL OF EVIDENCE

Level III, therapeutic study.

摘要

背景

伯明翰髋关节表面置换(BHR)假体是最常用的金属对金属髋关节表面置换关节成形术装置。目前制造商推荐的BHR目标人群为年龄小于65岁、股骨头尺寸≥50mm的男性患者。已知女性患者、老年患者以及股骨头直径较小(≤50mm)的个体翻修率较高。先前的研究表明,在目标人群中使用BHR时的假体生存率与初次传统全髋关节置换术(THA)相当,但将最耐用的髋关节表面置换关节成形术装置的生存率与所有传统THA假体的生存率进行比较并不理想,因为THA组包含大量不同类型的假体,其假体生存率存在相当大的差异。更具参考价值的比较是与生存率最佳的THA植入物进行比较,因为这可能有助于解决在BHR目标人群中使用性能良好的传统THA是否可以提高生存率的问题。

问题/目的:我们比较了向澳大利亚骨科协会国家关节置换登记处(AOANJRR)报告的使用BHR假体(股骨头尺寸>50mm)和三种传统THA假体的手术的累积翻修百分比、翻修原因和翻修类型的差异,这三种传统THA假体在当前推荐的BHR目标人群中10年累积翻修百分比最低,以探讨:(1)BHR的累积翻修率是否低于三种传统THA假体组?(2)BHR与三种最佳传统THA假体的翻修诊断是否存在差异?(3)与三种最佳传统THA假体相比,BHR翻修时使用的组件有何差异?

方法

本分析使用了1999年9月1日至2018年12月31日期间向AOANJRR报告的数据。该研究期几乎涵盖了BHR在澳大利亚的全部使用情况。AOANJRR是一个大型的国家关节登记处,完整性几乎达到100%,准确性高,经过严格验证,随访失访率极低。研究人群包括年龄小于65岁、因骨关节炎接受过一次髋关节置换手术的男性。所有接受双侧手术的患者均被排除在外,无论双侧髋关节手术的时间间隔如何。仅纳入股骨头尺寸≥50mm的BHR假体以及股骨头尺寸≥32mm、采用陶瓷对陶瓷或金属、陶瓷、陶瓷化金属对交联聚乙烯(XLPE)轴承的传统THA假体。选择这些股骨头尺寸和轴承是因为它们反映了现代传统THA的实际应用情况。在AOANJRR中,这些轴承的翻修率没有差异。研究组中有4790例BHR手术和2696例传统THA手术。BHR手术的平均(±标准差)年龄为52±7.8岁,传统THA手术为56±7.1岁。所有比较分析均对年龄进行了调整。其他人口统计学数据,包括美国麻醉医师协会(ASA)评分和体重指数(BMI),分别自2012年和2015年起仅纳入AOANJRR数据收集,由于自那时起澳大利亚BHR的使用量较低,因此未纳入本分析。两组的最长随访时间均为18.7年,BHR组的平均随访时间为11.9年,传统THA组为9.3年。翻修率采用Kaplan-Meier生存估计法确定,以描述首次翻修的时间,并在分析时根据死亡时间或数据库关闭时间进行截尾。翻修定义为关节置换的任何组件的移除、更换或添加。翻修可进一步分为重大翻修(移除与骨相连的组件 - 通常是柄和/或髋臼杯)或微小翻修(移除其他组件 - 通常是股骨头和/或内衬)。计算初次关节成形术后未调整的累积翻修百分比(及其95%置信区间),并使用对年龄进行调整的Cox比例风险模型进行比较。

结果

BHR假体在17年时的全因翻修率在统计学上高于所选的传统THA假体(风险比[HR]2.77[95%置信区间1.78至4.32];p<0.001)。两组的翻修诊断不同,BHR在术后2年的松动翻修率高于传统THA假体(HR 4.64[95%置信区间1.66至12.97];p = 0.003),并且在整个期间的骨折率也更高(HR 2.57[95%置信区间1.24至5.33];p = 0.01)。与THA组相比,BHR在前5年的感染翻修率较低,此后两组之间无差异。BHR的所有翻修均为重大翻修(例如,移除或更换股骨和/或髋臼组件),这发生在4.5%的初次BHR手术中。重大翻修是初次THA最常见的翻修类型,占所有初次THA手术的1.7%。微小翻修(股骨头、内衬或两者)在另外0.6%的初次THA手术中进行。

结论

鉴于与目标人群中性能更好的传统THA假体相比,BHR的翻修风险增加,我们建议向患者告知这一风险。我们认为,具有经证实的低翻修率的THA可能是更好的选择,特别是对于那些关注植入物耐用性的患者。鉴于这种翻修风险,需要进行严格控制的前瞻性研究,以显示在患者报告的结局和功能结果方面存在明显的临床重要差异,表明BHR优于使用现代轴承的传统THA假体,才能证明使用BHR的合理性。

证据水平

III级,治疗性研究。

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