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临床假体移位研究中对RSA和CT-RSA指南项目的遵循情况:一项系统评价

Adherence to the RSA and CT-RSA guideline items in clinical prosthesis migration studies: a systematic review.

作者信息

Van der Lelij Thies J N, Koster Lennard A, Kaptein Bart L, Nelissen Rob G H H, Marang-van de Mheen Perla J

机构信息

Department of Orthopaedics, Leiden University Medical Center, Leiden, Zuid-Holland, the Netherlands.

Department of Orthopaedics, Leiden University Medical Center, Leiden, Zuid-Holland; Safety & Security Science and Centre for Safety in Healthcare, Delft University of Technology, Delft, Zuid-Holland, The Netherlands.

出版信息

Acta Orthop. 2025 May 27;96:380-386. doi: 10.2340/17453674.2025.43750.

Abstract

BACKGROUND AND PURPOSE

Standardized reporting on methodology and results in clinical RSA research papers facilitates evaluation of quality and interpretation of results. We aimed to assess the extent to which radiostereometric analysis (RSA) and computed tomography-based RSA (CT-RSA) studies adhered to the items of the new RSA reporting guideline from 2024.

METHODS

A systematic literature search was performed to identify all clinical RSA studies published between January 2012 and February 2024. Studies were eligible for inclusion if prosthesis migration over time was assessed. The adherence of studies to each applicable guideline item (full, partial, or no) was assessed.

RESULTS

285 studies were included, most of which assessed prosthesis migration in the hip (n = 161) or knee (n = 99). No study reported on all guideline items. The mean (full or partial) adherence of studies to all (applicable) items was 61% (standard deviation [SD] 11). Large variation between the reporting of items was found, ranging from being reported in 1% of the studies to 100%. The least reported items in studies were the mean number and SD of days between surgery and baseline RSA examination (8% of studies), mean number and SD of days between surgery and primary endpoint RSA examination (1%), and consistent- or all-marker method for RSA analysis (3%).

CONCLUSION

Current studies on average reported only 61% of the items from the updated RSA guidelines. Adherence to the guidelines in clinical RSA studies on prosthesis migration should be improved, in order to improve the quality of studies and the interpretation of outcomes on implant migration.

摘要

背景与目的

临床RSA研究论文中关于方法和结果的标准化报告有助于评估质量和解读结果。我们旨在评估放射性立体测量分析(RSA)和基于计算机断层扫描的RSA(CT-RSA)研究遵循2024年新RSA报告指南各项内容的程度。

方法

进行系统的文献检索,以识别2012年1月至2024年2月期间发表的所有临床RSA研究。如果评估了假体随时间的移位情况,则这些研究符合纳入标准。评估研究对每个适用指南项目(完全、部分或无)的遵循情况。

结果

纳入了285项研究,其中大多数评估了髋关节(n = 161)或膝关节(n = 99)的假体移位情况。没有研究报告所有指南项目。研究对所有(适用)项目的平均(完全或部分)遵循率为61%(标准差[SD] 11)。发现项目报告之间存在很大差异,从1%的研究报告到100%的研究报告不等。研究中报告最少的项目是手术与基线RSA检查之间的天数的平均数和标准差(8%的研究)、手术与主要终点RSA检查之间的天数的平均数和标准差(1%)以及RSA分析的一致或全标记方法(3%)。

结论

目前的研究平均仅报告了更新后的RSA指南中61%的项目。应提高临床RSA研究中关于假体移位的指南遵循率,以提高研究质量和对植入物移位结果的解读。

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