Public trial
RBR-94qz3ym Study of infected hip and knee joint prostheses using the sonication technique
Date of registration: 02/12/2021 (mm/dd/yyyy)Last approval date : 02/12/2021 (mm/dd/yyyy)
Study type:
Observational
Scientific title:
en
Epidemiological and microbiological study of hip and knee infected arthroplasties using the sonication technique
pt-br
Estudo epidemiológico e microbiológico das artroplastias infectadas de quadril e joelho usando a técnica de sonicação
Trial identification
- UTN code: U1111-1258-8599
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Public title:
en
Study of infected hip and knee joint prostheses using the sonication technique
pt-br
Estudo das próteses articulares de quadril e joelho infectadas usando a técnica de sonicação
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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Número do CAAE: 70462117.0.0000.5479
Issuing authority: Plataforma Brasil
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Número do Parecer do CEP: 2.195.577
Issuing authority: Comitê de Ética em Pesquisa da Santa Casa de Misericórdia de São Paulo
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Número do CAAE: 70462117.0.0000.5479
Sponsors
- Primary sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
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Secondary sponsor:
- Institution: Faculdade de Ciências Médicas da Santa Casa de São Paulo
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Supporting source:
- Institution: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Health conditions
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Health conditions:
en
hip and knee prosthetic joint infection Sonication. Arthroplasty. Prosthesis-related infections /diagnosis. Biofilm. Tissue Culture Techniques.
pt-br
infecção de prótese articular de quadril e joelho Sonicação. Artroplastia. Infecções relacionadas à prótese/ diagnóstico. Biofilme. Técnicas de cultura de tecido.
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General descriptors for health conditions:
en
C01.685 Prosthesis-Related Infections
pt-br
C01.685 Infecções relacionadas à prótese/diagnóstico
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Specific descriptors:
en
E05.848 Sonication
pt-br
E05.848 Sonicação
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A20.593 Biofilm
pt-br
A20.593 Biofilme
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E05.481.500.617 Tissue Culture Techniques
pt-br
E05.481.500.617 Técnicas de cultura de tecidos
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E04.555.110.110 Arthroplasty
pt-br
E04.555.110.110 Artroplastia
Interventions
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Interventions:
en
Prosthesis replacement due to suspected infection Tissue and sonication culture 146 patients
pt-br
Revisão de prótese de quadril e joelho por suspeita de infecção Cultura de tecido e da sonicação 146 pacientes
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Descriptors:
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E04.690 Reoperation
pt-br
E04.690 Cirurgia de revisão
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C01.685 Prosthesis-Related Infections
pt-br
C01.685 Infecções relacionadas à protese
Recruitment
- Study status: Data analysis completed
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Countries
- Brazil
- Date first enrollment: 09/01/2010 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 146 - 18 Y 100 Y -
Inclusion criteria:
en
All patients who underwent total and partial hip and knee arthroplasties, with the implant removed for sonication.
pt-br
Todos os pacientes submetidos à cirurgia de revisão de artroplastias totais e parciais de quadril e joelho, com envio do implante retirado para sonicação.
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Exclusion criteria:
en
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.
pt-br
Ausência da coleta de tecido peri-protético no intra-operatório; Contaminação óbvia dos implantes ortopédicos durante a sua retirada e ou transporte; Pacientes cujas artroplastias não foram submetidas à sonicação por indisponibilidade de recipientes adequados para transporte do implante no momento da retirada ou pela ausência de recipientes na instituição.
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase Diagnostic Single-group 1 N/A N/A N/A
Outcomes
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Primary outcomes:
en
To evaluate the performance of implant sonication cultures compared to tissue cultures in the diagnosis of prosthetic joint infection, using the modified clinical criterion, and the diagnostic criteria proposed by International Consensus Meeting (ICM), Infectious Disease Society of America (IDSA) e European Bone and Joint Society (EBJIS); were used to compare the performance of microbiological tests McNemar´s test and proportion comparison were employed to calculate p-value; sensitivity, specificity, positive predictive value, negative predictive value and accuracy of each test were calculated using the proposed diagnostic criteria.
pt-br
Avaliar o desempenho das culturas do fluido de sonicação dos implantes em comparação às culturas de tecidos no diagnóstico de infecção de prótese articular, utilizando o critério clínico modificado, e os critérios diagnósticos propostos pelo International Consensus Meeting (ICM), Infectious Disease Society of America (IDSA) e European Bone and Joint Society (EBJIS); o teste de McNemar e comparação de proporções foram usados para calcular o valor do p na comparação da performance dos testes microbiológicos; cálculo de sensibilidade, especificidade, valor preditivo positivo, valor preditivo negativo e acurácia de cada teste usando os critérios diagnósticos propostos.
en
Describe the epidemiological aspects of the patients; descriptive; mean, median and standard deviation were calculated for numerical variables.
pt-br
Descrever os aspectos epidemiológicos dos pacientes estudados; descritivo; cálculo de média, mediana e desvio padrão para as variáveis numéricas.
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Secondary outcomes:
en
Describe the microbiological profile of infections of primary joint prosthesis and revision prosthesis; descriptive
pt-br
Descrever o perfil microbiológico das infecções de prótese articular primária e prótese de revisão; descritivo
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Describe cultures with discordant and discrepant pathogens found in the two different tests used (tissue culture and sonicated fluid); descriptive
pt-br
Descrever as culturas com patógenos discordantes e discrepantes encontradas nos dois diferentes testes usados (cultura de tecido e do fluido sonicado); descritivo
Summary Results
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Baseline char:
en
Bone and joint infection
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Participants flow:
en
Bone and joint infection
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Results summary:
en
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.
Data Sharing Plan
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Data Sharing Plan:
en
Yes
Contacts
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Public contact
- Full name: Taiana Cunha Ribeiro
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- Address: R. Dr. Cesário Mota Júnior, 112
- City: São Paulo / Brazil
- Zip code: 01221-010
- Phone: (+55)11966216446
- Email: taiana_7@hotmail.com
- Affiliation:
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Scientific contact
- Full name: Taiana Cunha Ribeiro
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- Address: R. Dr. Cesário Mota Júnior, 112
- City: São Paulo / Brazil
- Zip code: 01221-010
- Phone: (+55)11966216446
- Email: taiana_7@hotmail.com
- Affiliation:
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Site contact
- Full name: Taiana Cunha Ribeiro
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- Address: R. Dr. Cesário Mota Júnior, 112
- City: São Paulo / Brazil
- Zip code: 01221-010
- Phone: (+55)11966216446
- Email: taiana_7@hotmail.com
- Affiliation:
Additional links:
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