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氧化锆与钴铬合金在初次全膝关节置换中的比较:美国关节置换登记处的中期翻修率无差异。

Oxidized Zirconium Versus Cobalt Chromium for Primary TKA: No Difference in Midterm Revision Rates From the American Joint Replacement Registry.

机构信息

Department of Orthopaedic Surgery and Rehabilitation, Wake Forest School of Medicine, Winston-Salem, NC, USA.

Centre for Sport, Exercise and Osteoarthritis Research Versus Arthritis, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

出版信息

Clin Orthop Relat Res. 2023 Aug 1;481(8):1553-1559. doi: 10.1097/CORR.0000000000002585. Epub 2023 Feb 28.

Abstract

BACKGROUND

Cobalt chromium (CoCr) is the most commonly used material in TKA; however, the use of oxidized zirconium (OxZr) implants has increased. The advantages to this material demonstrated in basic science studies have not been borne out in clinical studies to date.

QUESTION/PURPOSE: In the setting of the American Joint Replacement Registry (AJRR), how do revision rates differ between CoCr and OxZr after primary TKA?

METHODS

The AJRR was accessed for all primary TKAs performed between 2012 and 2020 for osteoarthritis, resulting in 441,605 procedures (68,506 with OxZr and 373,099 with CoCr). The AJRR is the largest joint replacement registry worldwide and collects procedure-specific details, making it ideal for large-scale comparisons of implant materials in the United States. Competing risk survival analyses were used to evaluate the all-cause revision rates of primary TKAs, comparing CoCr and OxZr implants. Data from the Centers for Medicare and Medicaid Services claims from 2012 to 2017 were also cross-referenced to capture additional revisions from other institutions. Revision rates were tabulated and subclassified by indication. Multivariate Cox regression was used to account for confounding variables such as age, gender, region, and hospital size.

RESULTS

After controlling for confounding variables, there were no differences between the OxZr and CoCr groups in terms of the rate of all-cause revision at a mean follow-up of 46 ± 23 months and 44 ± 24 months for CoCr and OxZr implants, respectively (hazard ratio 1.055 [95% confidence interval 0.979 to 1.137]; p = 0.16) The univariate analysis demonstrated increased rates of revisions for pain and instability in the OxZr group (p = 0.003 and p < 0.001, respectively).

CONCLUSION

These findings suggest there is no difference in all-cause revision between OxZr and CoCr implants in the short-term to mid-term. However, further long-term in vivo studies are needed to monitor the safety and all-cause revision rate of OxZr implants compared with those of CoCr implants. OxZr implants may be favorable in patients who have sensitivity to metal. Despite similar short-term to mid-term all-cause revision rates to CoCr implants, because of the limitations of this study, definitive recommendations for or against the use of OxZr cannot be made.

LEVEL OF EVIDENCE

Level III, therapeutic study.

摘要

背景

钴铬(CoCr)是 TKA 中最常用的材料;然而,氧化锆(OxZr)植入物的使用有所增加。基础科学研究中证明的这种材料的优势在迄今为止的临床研究中并未得到证实。

问题/目的:在美国家具置换登记处(AJRR)中,初次 TKA 后 CoCr 和 OxZr 的翻修率有何不同?

方法

AJRR 被用来获取 2012 年至 2020 年间因骨关节炎进行的所有初次 TKA 手术,共 441605 例(OxZr 组 68506 例,CoCr 组 373099 例)。AJRR 是全球最大的关节置换登记处,收集特定于手术的详细信息,非常适合在美国对植入物材料进行大规模比较。使用竞争风险生存分析评估初次 TKA 的全因翻修率,比较 CoCr 和 OxZr 植入物。还交叉参考了 2012 年至 2017 年医疗保险和医疗补助服务中心的索赔数据,以捕捉来自其他机构的额外翻修。列出并分类了按适应证的翻修率。多变量 Cox 回归用于考虑年龄、性别、地区和医院规模等混杂变量。

结果

在控制混杂变量后,CoCr 和 OxZr 组在平均 46 ± 23 个月和 44 ± 24 个月的随访中,全因翻修率无差异(风险比 1.055 [95%置信区间 0.979 至 1.137];p = 0.16)。单变量分析显示 OxZr 组疼痛和不稳定的翻修率增加(p = 0.003 和 p < 0.001)。

结论

这些发现表明,在短期至中期,OxZr 和 CoCr 植入物之间的全因翻修率没有差异。然而,需要进一步的长期体内研究来监测 OxZr 植入物与 CoCr 植入物相比的安全性和全因翻修率。对于对金属敏感的患者,OxZr 植入物可能是有利的。尽管短期至中期全因翻修率与 CoCr 植入物相似,但由于本研究的局限性,不能对使用 OxZr 做出明确的推荐或反对。

证据等级

三级,治疗性研究。

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