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临床试验/RBR-94qz3ym
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Epidemiological and microbiological study of hip and knee infected arthroplasties using the sonication technique

Faculdade de Ciências Médicas da Santa Casa de São Paulo0 个研究点开始时间: 2021年2月12日最近更新:

试验速览

阶段
未知
状态
已完成
发起方

研究概览

简要总结

In the absence of a gold standard criterion for diagnosing prosthetic joint infections (PJI), some authors have shown that sonication of the removed implant may provide superior microbiological identification to synovial fluid and peri-implant tissue cultures, thereby improving PJI diagnosis. In this scenario, we propose to evaluate the performance of sonication cultures compared to tissue cultures in the PJI diagnosis and the epidemiological and microbiological profile of these infections. Methods: A retrospective study of 146 patients undergoing removal of hip or knee prosthetic joints due to any reason and submitted to implant sonication between 2010 and 2018 was conducted at a tertiary hospital in São Paulo, Brazil. In the absence of a gold standard criterion for diagnosing PJI, the following diagnostic criteria were used to compare the performance of sonication fluid culture versus periprosthetic tissue cultures: ICM-2018, IDSA, EBJIS criteria, and a modified clinical criterion. Sonication fluid and tissue cultures were performed according to published standardized protocols. Statistical analysis was carried out using McNemar´s test and proportion comparison was employed to calculate p-value. Results: Of total patients assessed, 56% (82/146) were diagnosed with PJI using the clinical criteria. Out of these cases, 57% (47/82) tested positive on tissue culture versus 93% (76/82) on sonication culture. Applying the clinical criteria, sonication fluid cultures showed 92.7% sensitivity (95% CI: 87.1%- 98.3%), tissue cultures 57.3% (95% CI: 46.6%- 68.0%) (p<0.001) and the two methods combined showed 96,3% sensitivity (95% CI: 91.5%- 100%). Sonication culture and the combination of the sonication cultures with tissue cultures showed a higher sensitivity than tissue cultures alone for all diagnostic criteria used. Sonication cultures were also more sensitive than tissue cultures for some subgroups of patients with clinically PJI: patients with prothesis placed more than 24 months, visible purulent secretion, positive histology and previous antimicrobial use. Use of sonication fluid culture in association with tissue culture improved diagnostic accuracy. Conclusions: The sonication technique improved microbiological identification in patients undergoing hip or knee prosthetic joint revision for any reason. In a context where diagnostic criteria available have shortcomings and tissue cultures remain the gold standard, tissue sonication can aid PJI diagnosis. Sonication is especially useful when diagnosis employing the criteria is inconclusive due to missing data (joint puncture, histology, or preoperative laboratory exams), the periprosthetic tissue sample available for collection is small, and the sample processing method is not ideal.

研究设计

研究类型
Observational

入排标准

年龄范围
18Y 至 100Y(—)

入选标准

  • All patients who underwent total and partial hip and knee arthroplasties, with the implant removed for sonication.

排除标准

  • Absence of collection of peri-prosthetic tissue in the intraoperative moment; Obvious contamination of orthopedic implants during their removal and/ or transport; Patients whose arthroplasties were not submitted to sonication due to the unavailability of suitable containers for transporting the implant at the time of removal or the absence of containers in the institution.

研究者

发起方
Faculdade de Ciências Médicas da Santa Casa de São Paulo

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