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评估初次全膝关节置换假体的比较性能时,最适合使用的对照物是什么?一项基于登记处的研究。

What Is the Most Appropriate Comparator to Use in Assessing the Comparative Performance of Primary Total Knee Prostheses? A Registry-Based Study.

作者信息

Ghadirinejad Khashayar, Graves Stephen, de Steiger Richard, Pratt Nicole, Solomon Lucian B, Taylor Mark, Hashemi Reza

机构信息

The Medical Device Research Institute, College of Science and Engineering, Flinders University, Clovelly Park, SA, Australia.

The Australian Orthopaedic Association National Joint Replacement Registry, Adelaide, SA, Australia.

出版信息

Arthroplast Today. 2024 Mar 16;27:101344. doi: 10.1016/j.artd.2024.101344. eCollection 2024 Jun.

Abstract

BACKGROUND

The Australian Orthopedic Association National Joint Replacement Registry has developed a standardized multi-stage approach to identify prostheses with a higher-than-anticipated rate of revision when comparing a prosthesis of interest to all other prostheses within the same broad class. However, the approach does not adequately differentiate between the conventional and complex design prostheses, and the comparator classes need to be re-evaluated. This study aimed to identify a more relevant comparator to better reflect conventional and complex surgical practices according to the stability design and also explore how the rate of revision estimated in the comparator groups affects the identification of "."

METHODS

The cumulative percent revision (CPR) was calculated for 640,045 primary total knee replacements (TKRs) undertaken for Osteoarthritis from 1 January 2003 to 31 December 2019. At first, survivorship analyses were undertaken to calculate the rate of revision for primary TKR by stability design. A modified TKR comparator group was developed by excluding the "complex" group of prostheses with fully stabilized and hinged designs. The effectiveness of the modified comparator groups, including cruciate retaining and posterior stabilized designs, was evaluated based on the ability to detect additional prostheses by performing the Australian Orthopedic Association National Joint Replacement Registry standardized method for identifying prosthesis outliers.

RESULTS

The modified comparator to include only conventional designs had a 10-year CPR of 5.2% (5.1, 5.3). When the fully stabilized and hinged design groups were combined as a comparator group of complex devices to reflect devices used only for specific purposes in primary TKR, the CPR at 10 year was 10.3% (8.6, 12.0).

CONCLUSIONS

The use of modified comparator groups led to identifying additional conventional prostheses but fewer complex designs as being at risk and has the potential to improve the early assessment of TKR prostheses.

摘要

背景

澳大利亚骨科协会国家关节置换登记处已制定了一种标准化的多阶段方法,用于在将感兴趣的假体与同一大类中的所有其他假体进行比较时,识别翻修率高于预期的假体。然而,该方法未能充分区分传统设计和复杂设计的假体,比较类别需要重新评估。本研究旨在确定一个更相关的比较组,以根据稳定性设计更好地反映传统和复杂的手术实践,并探讨比较组中估计的翻修率如何影响“.”的识别。

方法

计算了2003年1月1日至2019年12月31日期间因骨关节炎进行的640,045例初次全膝关节置换术(TKR)的累积翻修百分比(CPR)。首先,进行生存分析以计算按稳定性设计的初次TKR的翻修率。通过排除具有完全稳定和铰链设计的“复杂”假体组,开发了一个改良的TKR比较组。基于通过执行澳大利亚骨科协会国家关节置换登记处识别假体异常值的标准化方法检测额外假体的能力,评估了改良比较组(包括保留交叉韧带和后稳定设计)的有效性。

结果

仅包括传统设计的改良比较组的10年CPR为5.2%(5.1,5.3)。当将完全稳定和铰链设计组合并为复杂装置的比较组以反映仅用于初次TKR特定目的的装置时,10年时的CPR为10.3%(8.6,12.0)。

结论

使用改良的比较组可识别出更多有风险的传统假体,但识别出的复杂设计假体较少,并且有可能改善TKR假体的早期评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1351/10958059/a5dd7eb6063c/gr1.jpg

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