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Effectiveness of intra-articular vancomycin in preventing prosthetic joint infections in hip and knee arthroplasty: A systematic review and meta-analysis of RCT's
, Elcio Machinskib, André Richard da Silva Oliveira Filhoc, Rodrigo Arruda Conded, Bruno Butturi Varonee, Riccardo Gomes Gobbie,f, Camilo Partezani Helitoe, Daniel Peixoto Leale
⁎Corresponding author: Vinícius Furtado da Cruz. vfurtadodacruz@gmail.com
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Received: ,
Accepted: ,
This article was originally published by Reed Elsevier India Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.
Abstract
Abstract
This study aimed to evaluate the effectiveness and safety of intra-articular vancomycin powder in reducing prosthetic joint infections (PJIs) in primary hip and knee arthroplasty through a meta-analysis of randomized controlled trials (RCTs).
A research in Pubmed, Embase and Cochrane databases was performed to identify randomized clinical trials comparing intra-articular vancomycin use to conventional antibiotic prophylaxis in total hip or knee arthroplasty patients, assessing postoperative infection rates, adverse drug reactions, and venous thrombotic events. Statistical analysis was performed using R (RStudio 2024.04.2), and heterogeneity was assessed with the I2 test.
A total of 1485 patients from five randomized clinical trials were included, with 737 receiving intra-articular vancomycin. The infection rate was 0.54 % in the intervention group and 1.73 % in the control group (RR 0.37; 95 % CI 0.02–8.95; p = 0.369; I2 = 49 %), showing no statistically significant difference between the groups. Adverse reactions to the glycopeptide were reported in six cases (0.8 %) in the intervention group compared to four cases (0.5 %) in the control group (RR 1.50; 95 % CI 1.50–150; p = 0.001; I2 = 0 %). Regarding thrombotic events, there was one case in 647 patients in the intervention group and three cases in 660 patients in the control group (RR 0.45; 95 % CI 0.03–7.02; p = 0.169; I2 = 0 %).
Although no significant difference was found, the intervention group showed a trend toward lower infection rates. Additional RCTs with larger sample sizes are required to confirm these findings.
The prospective registration of the meta-analysis was conducted on PROSPERO in July 2024 with the protocol number 565988.
Keywords
Vancomycin
Knee arthroplasties
Hip arthroplasties
Prosthetic joint infection
1 Introduction
The global rise in osteoarthritis prevalence has led to a steady increase in the annual number of hip and knee arthroplasties. In the United States, nearly one million of these procedures are performed each year, with prosthetic joint infection (PJI) being a significant concern among physicians.1 Trends in PJI prevalence have varied, with some studies reporting a decline while others indicate an increase.2–4 In the U.S., PJIs account for an estimated annual financial burden of $1.8 billion.5 Risk factors for PJI include comorbidities, immunosuppression, and a history of previous infections.6,7
Preventive measures for postoperative infection have been widely studied, including protocols within the surgical center, prophylactic antibiotic therapy, decolonization of S. aureus with mupirocin, and chlorhexidine baths.8–10 Despite these measures, infections are a major concern, as their occurrence can lead to significant impairments in mobility, daily activities, and even life-threatening risks.
One approach to preventing these periprosthetic joint infections (PJI) is the use of local antibiotics, with vancomycin showing satisfactory results in some studies due to its relative affordability, broad-spectrum antibacterial properties, and ability to achieve good tissue concentration without systemic adverse effects.11–16 Despite promising results, the evidence supporting intra-articular vancomycin remains limited, highlighting the need for further high-quality research.15,17,18
Therefore, this meta-analysis of Randomized Clinical Trials (RCT) aims to evaluate the efficacy of intra-articular vancomycin powder in preventing PJI in primary hip and knee arthroplasties. We hypothesize that the use of intra-articular vancomycin is effective in preventing PJI.
2 Material and methods
2.1 Study eligibility (inclusion and exclusion criteria)
This systematic review with meta-analysis was conducted in accordance with the Cochrane Collaboration Handbook for Systematic Review of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Only studies meeting the following eligibility criteria were included in this meta-analysis1: RCTs2; compared standard prophylaxis + intra-articular vancomycin with standard prophylaxis only3; involved patients undergoing primary hip or knee arthroplasty4; reported the infection rate. No minimum follow-up time was established as an inclusion criterion for this review. Articles were excluded if they1: involved prosthesis revision cases2; were observational studies3; lacked a control group.
2.2 Literature search
A systematic search was conducted in PubMed, Embase, and Cochrane databases in June 2024 using the following terms: “knee arthroplasty”, “knee replacement”, “hip arthroplasty”, “hip replacement”, “vancomycin”, and “intra-articular antibiotic”. The references of all included studies in previous systematic reviews and meta-analyses were manually reviewed to identify additional studies that could contribute to the meta-analysis but were not linked in the three databases we searched. This search found the paper “Effectiveness and safety of vancomycin powder injection locally applied in the prevention of prosthetic joint infection” by Wu, X. et al., 2022. The prospective registration of the meta-analysis was conducted on PROSPERO in July 2024 with the protocol number 565988.
2.3 Study selection and data abstraction
Using the search strategy, we found 335 results. The Rayyan software was used for blinded screening and study selection, generating summaries for included and excluded articles, as well as those on which the authors disagreed regarding their inclusion or exclusion. This feature facilitates further discussion among the team.19 After removing duplicate studies, two authors independently and blindly conducted the selection according to the inclusion criteria. Discrepancies were discussed with the senior author. With this, 4 randomized clinical trials remained. Additionally, from previous meta-analyses, we identified the article “Effectiveness and safety of vancomycin powder injection locally applied in the prevention of prosthetic joint infection” by Wu, X et al., 2022 that was not published in a journal indexed in the databases we defined for review but may influence the meta-analysis. Thus, a total of 5 RCTs comparing 1477 patients were included. Of these, 737 patients (49.9 %) received the intervention. The studies by Wang and Wu were the only ones that included hip arthroplasty, with 60 patients (30 from each study) receiving vancomycin in this joint. The study selection data and the main characteristics of the included studies are presented in Fig. 1 and Table 1, respectively.
| Study, year | Diagnostic criteria to PJI | Type of study | N. total | Patients IT/CT | Age IT/CT | Local | Center | Follow-Up | Male sex IT/CT | TKA IT/CT | BMI IT/CT | DM IT/CT | CKD IT/CT | Smoking IT/CT | Intervention |
| Abuzaiter, 2023 | MSIS criteria | RCT | 165 | 80/85 | 66/64 | Canada | Single | 6 weeks | 29/33 | 80/85 | 33,5/35,7 | 16/13 | 3/1 | 9/4 | IV antibiotics (2–3 g of Cefazolin) + 1 g of VP |
| Mulpur, 2024 | MSIS criteria | RCT | 1022 | 507/515 | 61.7/61.4 | India | Single | 12 months | 147/157 | 507/515 | 28.5/28.4 | 170/161 | 2/4 | 58/60 | 1.5 g IV of Cefuroxime + 2 g VP + 2 doses of 1.5 g IV of Cefuroxime |
| Wang, 2023 | Alexander's criteria | RCT | 90 | 45/45 | 67.9/68.0 | China | Single | 3 months | 24/23 | 15/16 | SD | SD | SD | SD | 1 g of Cefazolin + 1 g VP + 6 doses of 1 g of Cefazolin |
| Wu, 2022 | Alexander's criteria | RCT | 90 | 45/45 | 67.9/68.0 | China | Single | 3 months | 24/23 | 15/16 | SD | SD | SD | SD | 1 g of Cefazolin + 1 g VP + 6 doses of 1 g of Cefazolin |
| Zhengyuan, 2024 | Alexander's criteria | RCT | 120 | 60/60 | 68.3/66.5 | China | Single | 12 months | 9/10 | 60/60 | 25.8/26.2 | SD | SD | SD | 1.5 g of Cefuroxime + 1 g VP + 2 doses of 1.5 g of Cefuroxime |
2.4 Risk of bias assessment
We conducted the risk of bias analysis of the randomized studies using version 2 of the Cochrane Risk of Bias tool (RoB2).20 Two authors independently performed the analysis. Discrepant results were discussed and resolved by consensus. The publication bias was investigated by the funnel-plot analysis of point estimates in relation to study weights. Following Cochrane's recommendations, Egger's test was not performed due to the inclusion of fewer than ten studies in this meta-analysis. Due to the heterogeneity of the results, the leave-one-out strategy was also conducted to mitigate study biases21
2.5 Data analysis
The primary outcomes were PJI rate, adverse drug reactions, and deep vein thrombosis. Fever, acute myocardial infarction, and length of hospital stay were also evaluated. The definition of prosthetic infection was established according to Alexander's diagnostic criteria or Musculoskeletal Infection Society (MSIS) criteria of 2018.22–24 The main differences between the included studies were reported in Table 1.
Alexander's criteria include a sinus tract at the treatment site connected to the joint, along with two of the following criteria: a) positive bacterial culture from suspected joint fluid; b) significant increase in neutrophils; c) clinical and laboratory correlation (systemic fever, joint pain, IL-6, hs-CRP, and imaging exams - X-ray, computed tomography, or magnetic resonance imaging). This criterion was used in the Chinese studies included in this review, but it is not widely recognized or well-documented in the scientific literature. It can be observed that it combines elements from more validated criteria in the literature, such as the criteria from the European Bone and Joint Infection Society (EBJIS) from 2021, the criteria from the International Consensus Meeting (ICM) from 2018, the criteria from the ICM from 2013, the guidelines from the Infectious Disease Society of America from 2013, and the criteria from the Musculoskeletal Infection Society (MSIS) from 2011.22–28
The relative risk (RR) with a 95 % confidence interval was used to compare the treatment effect on each binary outcome. We measured heterogeneity with the I2 statistical test and the Cochrane Chi2 test; a P-value <0.10 and I2 > 25 % were considered significant for heterogeneity. We conducted the statistical analysis using R software (RStudio 2024.04.2).
2.6 Trial Sequential Analysis
Trial Sequential Analysis (TSA) was conducted to assess the robustness of the findings and the risk of type I error in the context of repeated interim analyses. The analysis was performed using version 0.9.5.10 Beta of the TSA software. The TSA was configured with a two-sided significance level of 5 % (alpha = 0.05), a statistical power of 80 % (beta = 0.20), and the O'Brien-Fleming method was applied to adjust the significance thresholds.29–33
A sample size-based analysis (Fig. 8A) was performed, wherein the Required Information Size (RIS) was calculated to determine the total number of patients needed to draw statistically reliable conclusions based on the cumulative data from the included studies. Additionally, an event size-based analysis (Fig. 8B) was conducted, in which the Required Event Size (RES) was calculated to determine the cumulative number of events needed to achieve robust statistical significance.
In both analyses, the cumulative Z-curves were compared to the adjusted significance thresholds, allowing for the identification of whether the available evidence was conclusive or if additional studies would be necessary to confirm the results.
3 Results
3.1 Statistical analysis
3.1.1 Prosthetic joint infection rate
The PJI rate was 0.54 % in the intervention group and 1.73 % in the control group (RR 0.37; 95 % CI 0.02–8.95; p = 0.396; I2 = 49 %; Fig. 2). The p-value is at the threshold of statistical significance; however, the I2 test indicates high heterogeneity, and the confidence interval reflects substantial uncertainty about the effect estimate.
3.1.2 Adverse effects
Six adverse reactions (0.8 %) were reported in the intervention group compared to four (0.5 %) in the control group (RR 1.50; 95 % CI 1.50–1.50; p = 0.001 - Fig. 3). Therefore, there is no significant difference between the groups, nor is there any heterogeneity among the studies.
3.1.3 Deep vein thrombosis
Concerning deep venous thrombosis, there was one case among 647 patients in the intervention group and three cases among 660 patients in the control group (RR 0.45; 95 % CI 0.03–7.02; p = 0.169; I2 = 0 %; Fig. 4). Despite the wide confidence interval, likely due to the low number of DVT cases, there is no heterogeneity among the studies, nor is there a significant difference between the groups.
3.2 Risk of bias
Based on the RoB2 tool, all studies were classified as low risk of bias across all domains, as shown in Fig. 5. The funnel plot analysis revealed no evidence of publication bias, once all of the studies were located within the diagonal dotted lines. However, the studies were clustered closer to the diagonal lines and positioned lower on the y-axis, suggesting they have less precise (Fig. 6).
3.3 Trial Sequential Analysis
TSA was used to determine if the cumulative sample size met the thresholds for robust conclusions, employing the O'Brien-Fleming method.
The Trial Sequential Analysis (TSA – Fig. 8) indicated that, with a cumulative sample size of 1367 participants, the threshold to achieve robust information was not reached (4561 participants required). Furthermore, the Z-curve did not cross the boundaries for statistical significance, suggesting that the current evidence is insufficient to confirm or refute the hypothesis regarding the intervention.
4 Discussion
In this systematic review and meta-analysis of randomized clinical trials, five studies and 1477 patients were included. The efficacy of intra-articular vancomycin in reducing infection rates in hip and knee arthroplasties was compared. The main findings include1: there was no significant difference in prosthetic infection rates,2 adverse reactions occurred in 0.8 % of the intervention group and 0.5 % of the control group, without statistically significant difference,3 deep vein thrombosis was rare and not significantly different between groups.
With the significant growth in the number of arthroplasties performed worldwide, concerns regarding PJI rates have also increased. Consequently, numerous measures aimed at reducing these infection rates have been adopted,9,34 such as appropriate antibiotic prophylaxis,11 prior skin decolonization using germicidal chlorhexidine and mucosal mupirocin, irrigation with bactericidal solutions,35 special dressings,36 among others. However, some practices in clinical settings such as intra-articular vancomycin have become routine in certain centers but lack statistical confirmation of their efficacy.
Our findings contrast with recent meta-analyses, such as Gao et al. (2024),15 which included non-randomized studies and reported a significant reduction in PJIs with vancomycin. This paper included 22 studies with 23,363 arthroplasties between primary and revision arthroplasties (9545 in the intervention group), of which only 3 were randomized, contributing 345 patients. In a subgroup analysis comparing Vancomycin powder application or not in primary arthroplasties, 6 studies with a total of 2042 interventions (5704 controls) were included, demonstrating a potential statistically significant reduction in PJI rates (RR 0.4; 95 % CI 0.22–0.74; P = 0.64; I2 = 0 %). Gao et al. highlighted limitations in their meta-analysis, such as the predominance of level III studies, quality scores (NOS) between 6 and 8, and inclusion of confounding variables. The study by Gao et al. and also the study by Movassaghi et al.18 concluded that new randomized clinical trials are needed to validate this practice.
Since the study by Gao et al., two new randomized studies have been published, adding 1142 patients. Mulpur et al.37 included 1022 patients, followed them for 12 months, and concluded that intra-articular vancomycin did not significantly reduce prosthesis infection rates (1 event in the intervention group and 3 in the control group) and was associated with more aseptic complications, such as wound infiltration, maceration, and stitch abscess. Zhengyuan38 included 120 patients, followed them for 12 months, and also found no significant difference in infection rates (no infections in either the intervention or control groups). Additionally, no complications such as infections, prosthesis loosening, or deep vein thrombosis were reported, nor were any adverse effects or allergic reactions associated with the use of vancomycin observed during the follow-up.
In this latest systematic review with meta-analysis, three RCTs were included. Abuzaiter et al.39 involved 165 patients followed for six weeks, reporting three cases of infection in the experimental group and none in the control group; Wang et al.22 included 90 patients followed for three months, with no cases in the experimental group and six in the control group; Wu et al.23 included 90 patients followed for three months, with no cases in the experimental group and four in the control group.
Regarding postoperative antibiotic prophylaxis, all studies performed standard postoperative antibiotic prophylaxis, with the antibiotic administered up to 1 h before the surgical incision and maintained for the first 24 h”. However, the study performed by Abuzaiter et al.39 provided postoperative antibiotic prophylaxis to the control group, while the intervention group received only standard preoperative antibiotic prophylaxis up to 60 min before surgical incision. This difference in perioperative prophylaxis could be a confounding factor favoring the outcomes of the control group in this study.
Overall, our meta-analysis of randomized controlled trials (RCTs) contrasts with recent findings in the literature (meta-analyses that include prospective and retrospective studies, not necessarily randomized), as no statistical difference in infection rates was observed between the intervention and control groups. However, given the observed discrepancy in results and the trend toward positive outcomes in the intervention group, we decided to perform a Trial Sequential Analysis (TSA – Fig. 8).
This analysis revealed that the threshold of information required for robust conclusions was not reached. These findings highlight the need for future studies with larger sample sizes to validate the current evidence and minimize the risk of premature conclusions.
Due to the present heterogeneity of results among studies, particularly regarding the discrepant outcome of Abuzailer et al., we performed leave-one-out strategy.
The leave-one-out analysis revealed that, even with the exclusion of each study independently, the overall result of the meta-analysis remained consistent, showing no statistically significant difference between the two groups. The risk ratio varied between 0.16 and 0.61 across different analyses. However, this method demonstrated that the exclusion of Abuzailer et al. eliminated the heterogeneity among the studies, indicating that this particular study was responsible for the observed heterogeneity. When this study was excluded, the I2 dropped to 0 % and results have become more favorable to the intervention but no statistical difference between the approaches in the infection and complications were found. This may have occurred due to the low total number of patients in the RCTs. (Fig. 7).
Limitations found in this study include1: a smaller number of patients compared to previous meta-analyses, as those also included retrospective and non-randomized prospective studies; and2 lack of a larger number of prospective randomized studies3; The similar patient demographics and outcomes in Wu et al. and Wang et al. raise concerns about data authenticity, warranting further scrutiny.22,23 However, the papers presented different data on the infection and complication rates. To solve this limitations, it was performed the leave-one-out strategy and excluding one of the studies, there was no statistical difference in the results.
5 Conclusion
This meta-analysis of randomized controlled trials (RCTs) compares the association between periprosthetic joint infection (PJI) rates and the use or non-use of intra-articular vancomycin in primary hip and knee arthroplasties. Although the results do not provide sufficient evidence to support the routine use of vancomycin as prophylaxis, there is a potential effectiveness, requiring validation, in the group that received the glycopeptide. Additional randomized controlled trials are needed to validate the evidence and minimize the risk of premature conclusions.
Disclosures
All authors report no relationships that could be construed as a conflict of interest. All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation.
Authors' contributions
Vinícius Furtado da Cruz: First author. Responsible for assessing the project's feasibility, developing the search strategy, retrieving articles from databases, performing the screening process for inclusion or exclusion, conducting statistical analysis, and drafting the systematic review. Elcio Machinski: Second author. Responsible for reviewing the feasibility of the idea and the search strategy, performing the screening of articles for inclusion or exclusion, and verifying the outcomes reported in the studies for potential use in statistical analysis. André Richard da Silva Oliveira Filho: Responsible for ensuring the accuracy of data collection, reviewing the statistical analysis and interpreting the results. Rodrigo Arruda Conde: Responsible for guiding the statistical analysis and interpreting the results. Bruno Butturi Varone: Contributed to the writing of the introduction and discussion sections of the paper, provided guidance on the relevance of the research idea, and assisted in the statistical analysis guidance. Riccardo Gomes Gobbi: Responsible for reviewing the entire manuscript and providing suggestions for its improvement. Camilo Partezani Helito: Responsible for reviewing the entire manuscript and providing suggestions for its improvement. Daniel Peixoto Leal: Senior author. Responsible for overseeing all stages of the work, providing guidance on the writing of all sections, and conducting a thorough review of the manuscript. All authors approved the submitted version and agreed to take personal responsibility for their contributions. They also committed to ensuring that any issues related to the accuracy or integrity of any part of the work, even those in which they were not directly involved, are appropriately investigated, addressed, and documented in the literature.
Ethical approval and patient consent
This study is a systematic review and meta-analysis based on previously published data. As such, no new data involving human participants were collected, and no direct interaction with patients occurred. Therefore, obtaining patient consent or guardian approval was not required.
Ethical statement
This study is a systematic review and meta-analysis utilizing data from previously published studies. Since no new data collection or involvement of human participants occurred, ethical approval was not required.
Funding statement
This systematic review and meta-analysis received no financial support or funding from any company, institution, or organization. The authors conducted the research independently without external influence or sponsorship.
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