Abstract
Aim and hypothesis
To compare antibiotic prophylaxis with a single or multiple doses in total knee arthroplasty surgery. To assess whether the use of a multiple dose is justified in routine clinical practice. The starting hypothesis is that the use of multiple doses of prophylactic antibiotics does not reduce surgical infection and may increase costs, hospital stay and antibiotic resistance.
Methods
A systematic review and meta-analysis of the literature was carried out following the PRISMA guidelines. The search was carried out on 5 April 2024 in the PubMed and Cochrane Library databases by entering the terms: (antibiotic prophylaxis) AND ((total knee arthroplasty) OR (knee prosthesis)) and the Joanna Briggs Institute quality assessment tool was used to evaluate the quality of the included studies.
Results
Four articles have been included, all of which are retrospective cohort studies comparing the use of single-dose antibiotic prophylaxis with multiple-dose prophylaxis in total knee arthroplasty. No significant differences have been observed in terms of postsurgical infection rate between single- and multiple-dose prophylaxes.
Conclusions
The use of multiple-dose antibiotic prophylaxis in total knee arthroplasty has not been shown to reduce infections or other complications compared to single-dose antibiotic prophylaxis. No evidence has been found to justify the use of multiple-dose antibiotic prophylaxis in knee arthroplasty surgery.
Keywords: Antibiotic prophylaxis, Knee arthroplasty, Single-dose antibiotic, Multiple-dose antibiotic
Introduction
Prosthetic infection remains one of the most significant and serious complications of total knee arthroplasty. It has a profound social, economic, and clinical impact [1, 2]. The management of prosthetic infections frequently necessitates additional surgical interventions and prolonged intravenous and oral antibiotic therapy. The treatment of these infections usually requires the input of multiple specialists, including orthopedic surgeons, plastic surgeons, internists, infectious disease specialists and microbiologists [2].
The most effective method of reducing infection is the appropriate use of prophylactic antibiotics. Prophylactic antibiotics serve to rapidly reduce the quantity of bacteria within the joint. In order to achieve optimal results, an adequate quantity of antibiotic must be available at the time of the incision [3–5].
Numerous protocols and consensus articles have been proposed in an attempt to establish the optimal antibiotic prophylaxis regimen, including the choice of antibiotic, the number and timing of administrations, and the duration of therapy [3, 5–8]. The emergence of antibiotic resistance, as well as the associated costs, has prompted questions regarding the necessity of a multi-dose antibiotic regimen up to 24 or 48 h after surgery. There remains considerable controversy surrounding the optimal prophylactic antibiotic regimen for total knee arthroplasty. Different centers have adopted disparate protocols, while in others, the decision is made by the surgeon on a case-by-case basis.
Therefore, the question arises as to whether a single dose or multiple doses of antibiotics represent the optimal schedule for antibiotic prophylaxis. Does the administration of multiple doses of antibiotics offer any advantages over the administration of a single dose? The starting hypothesis is that the use of multiple doses of prophylactic antibiotics does not reduce surgical infection and may increase costs, hospital stay and antibiotic resistance.
The objective of this study was to compare the efficacy of single-dose antibiotic prophylaxis in total knee arthroplasty with that of multiple-dose antibiotic prophylaxis and to assess the justification of multiple-dose antibiotic prophylaxis for total knee arthroplasty in routine clinical practice.
Methods
A systematic review and meta-analysis was carried out following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [9]. The search was conducted on April 5, 2024, in the PubMed and Cochrane Central databases, entering the terms “antibiotic prophylaxis”, “total knee arthroplasty” and “knee prosthesis”. Keyword terms were combined using Boolean operators (AND) and (OR): (antibiotic prophylaxis) and ((total knee arthroplasty) or (knee prosthesis)). All abstracts and full texts were reviewed by two researchers; in case of disagreement on the selection of papers, they were discussed and, in case of doubt, assessed by another senior researcher to make a final decision. Bibliographic references were cross-checked (Fig. 1).
Fig. 1.
Flow diagram representing the bibliographic search performed
Inclusion criteria: (1) studies on antibiotic prophylaxis in primary total knee arthroplasty surgery comparing single-dose with multiple doses; (2) full text available in English or Spanish.
Exclusion criteria: (1) review articles and meta-analysis; (2) clinical cases and case studies without control or comparison group; (3) editorial letters and conference communications; (4) articles without clinical results; and (5) studies on animals.
Quality Assessment
The quality of the selected studies was evaluated with the Joanna Briggs Institute (JBI) checklist for cohort studies [10].
Data Analysis
Binary outcome of raw data (infections in primary total knee arthroplasty) was assessed through Odds Ratio (OR) with 95% CI. Publication bias was evaluated visually using funnel plot and statistically using the Egger regression test. Heterogeneity was assessed using the Q test and I2 statistics. Statistical significance for heterogeneity between studies was defined as p < 0.10 and I2 > 25%. The results indicate no heterogeneity, so the variables were included in a fixed-effects model to calculate statistics. Statistical analysis was performed using IBM SPSS Statistics v29.
Results
The search yielded 530 articles. After an initial screening, 48 duplicate articles were excluded, and 482 articles were selected for review (Fig. 1).
In this systematic review, 4 articles have been included that compared the use of single-dose antibiotics with multiple-dose antibiotics for infection prophylaxis in total knee arthroplasty [11–14]. Selected studies were evaluated with the Joanna Briggs Institute (JBI) checklist for cohort studies [10] (Table 1). The four selected papers are retrospective cohort studies, with a level of evidence III (Table 2).
Table 1.
JBI Critical Appraisal Checklist for cohort studies
| Veltman et al. [11] | Babu et al. [12] | Tan et al. [13] | Tang et al. [14] | |
|---|---|---|---|---|
| 1. Were the two groups similar and recruited from the same population? | YES | YES | YES | YES |
| 2. Were the exposures measured similarly to assign people to both exposed and unexposed groups? | YES | YES | YES | YES |
| 3. Was the exposure measured in a valid and reliable way? | YES | YES | YES | YES |
| 4. Were confounding factors identified? | YES | Unclear | YES | Unclear |
| 5. Were strategies to deal with confounding factors stated? | YES | Unclear | YES | Unclear |
| 6. Were the groups/participants free of the outcome at the start of the study (or at the moment of exposure)? | YES | YES | YES | YES |
| 7. Were the outcomes measured in a valid and reliable way? | YES | YES | YES | YES |
| 8. Was the follow-up time reported and sufficient to be long enough for outcomes to occur? | YES | YES | YES | YES |
| 9. Was follow-up complete, and if not, were the reasons to loss to follow-up described and explored? | YES | YES | YES | YES |
| 10. Were strategies to address incomplete follow-up utilized? | YES | Unclear | YES | YES |
| 11. Was appropriate statistical analysis used? | YES | Unclear | YES | YES |
| Overall score out of 11 (%) | 11 (100) | 7 (64) | 11 (100) | 9 (82) |
Table 2.
Articles included in the qualitative revision
| Author | Year | Study design | Source data | Level of evidence | N | Data collection period |
|---|---|---|---|---|---|---|
| Veltman et al. [11] | 2020 | Retrospective cohort | Dutch arthroplasty register | III | 111,467 | January 2011–December 2015 |
| Babu et al. [12] | 2020 | Retrospective cohort | Single hospital register | III | 4500 | January 2004–June 2013 |
| Tan et al. [13] | 2019 | Retrospective cohort | Single hospital register | III | 9329 | January 2006–June 2017 |
| Tang et al. [14] | 2003 | Retrospective cohort | Single hospital register | III | 917 | January 1991–December 1999 |
The papers analyze different antibiotic regimens in both single and multiple doses, as detailed in Table 3. The primary outcome measure across all studies was the percentage of infections occurring in the first year following surgery (Table 4).
Table 3.
Prophylactic antibiotic therapy administration guidelines
| Author | ATB Single-dose | N | ATB multiple-dose | N |
|---|---|---|---|---|
| Veltman et al. [11] | Cefazolin | 9880 | Cefazolin | 96,791 |
| Cefuroxime | 4796 | |||
| Babu et al. [12] | Flucloxacillin (1 g) + Gentamicin (120 mg) | 756 | Ind. Cefuroxime 1.5 g + Gentamicin 120 mg//Post Cefuroxime 750 mg 8 and 16 h post | 1880 |
| Ind Flucloxacillin 1 g + gentamicin 120 mg//Post Flucloxacillin 1 g 6, 12 y 18 h post | 480 | |||
| Teicoplanin (600 mg) + gentamicin (3 mg/kg) | 822 | |||
| Ind teicoplanin 400 mg + gentamicin 3 mg/kg//Post teicoplanin 400 mg 12 h | 562 | |||
| Tan et al. [13] | Cefazolin (15 mg/kg) or Vancomycin (1 g) | 1679 | Cefazolin (15 mg/kg/8 h; 1 dose ind, 2 dose post) or vancomycin (1 g/kg/12 h; 1 dose ind, 1 dose post) | 7650 |
| Tang et al. [14] | Cefazolin (1 g) | 792 | Cefuroxime (750 mg/8 h; 1 dose ind; 2 doses post) | 125 |
ATB antibiotic, ind anesthetic induction, post postoperative
Table 4.
Infections in primary total knee arthroplasty
| Author | Antibiotic regimen | N | Infections | Percentage of infection |
|---|---|---|---|---|
| Veltman et al. [11] | SD Cefazolin | 9880 | 24 | 0.24 |
| MD Cefuroxime | 4796 | 19 | 0.4 | |
| MD Cefazolin | 96,791 | 260 | 0.27 | |
| Babu et al. [12] | SD Flucloxacillin + Gentamicin | 756 | 9 | 1.19 |
| SD Teicoplanin + Gentamicin | 822 | 8 | 0.97 | |
| MD Cefuroxime + Gentamicin ind | 1880 | 18 | 1.01 | |
| MD Flucloxacillin + Gentamicin ind | 480 | 3 | 0.63 | |
| MD Teicoplanin + Gentamicin ind | 562 | 2 | 0.36 | |
| Tan et al. [13] | SD Cefazolin or Vancomycin | 1679 | 0.60a | |
| MD Cefazolin or Vancomycin | 7650 | 0.88a | ||
| Tang et al. [14] | SD Cefazolin | 792 | 8 | 1.01 |
| MD Cefuroxime | 125 | 2 | 1.6 |
aIn this paper this data is not expressed separating total knee prostheses and total hip prostheses
ind anesthetic induction, SD single-dose, MD multiple-dose
Heterogeneity among effect sizes of individual studies was not observed (Q = 2.57, df = 3, p-value = 0.46, I-squared = 0.00) and no publication bias was detected (Egger’s test t = 0.85 and p = 0.940). In the funnel plot, the effect sizes of individual studies fall within the funnel lines and are symmetrically distributed, indicating no publication bias (Fig. 2).
Fig. 2.
Funnel plot for publication bias assessment
Comparing the two antibiotic regimens, the estimated risk of infection was lower in patients who received single doses of prophylactic antibiotics in 3 studies [11, 13, 14], but higher in the study by Babu et al. [12]. When the patients from the 4 articles were combined, the estimated overall risk of infection was lower in patients who received single doses than in those who received multiple doses. However, these differences were not statistically significant (Fig. 3). The authors of the four papers conclude that there are no statistically significant differences in the use of the different antibiotic prophylaxis regimens studied in total knee arthroplasty [11–14].
Fig. 3.
Forest plot of primary endpoint: prosthetic joint infection
A pooled quantitative analysis of the influence of sex (female) and obesity was performed based on data provided by Veltman et al. [11], and Tan et al. [13]. With the limitation that Tan’s study does not present these data separately for total knee and total hip replacements, taken together, these potential confounders (female sex and obesity) did not significantly alter the risk of prosthesis infection in the single-dose and multiple-dose antibiotic groups (Table 5).
Table 5.
Estimated risk for infections in primary total knee arthroplasty in female and obese patients receiving single or multiple doses of prophylactic antibiotics
| Author | Sex (Female) | Obese | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Dose | Infected | OR for dose (95% CI) | Infected | OR for dose (95% CI) | |||||
| Yes | No | Total | Yes | No | Total | ||||
| Tan et al. [13]a | SD | 5 | 863 | 868 | 0.658 (0.258–1.679) | 7 | 729 | 736 | 0.956 (0.424–2.156) |
| MD | 37 | 4201 | 4238 | 36 | 3583 | 3619 | |||
| Total | 42 | 5064 | 5106 | 43 | 4312 | 4355 | |||
| Veltman et al. [11] | SD | 8 | 6550 | 6558 | 0.635 (0.311–1.298) | 8 | 1857 | 1865 | 1.224 (0.590–2.540) |
| MD | 127 | 66,055 | 66,182 | 76 | 21,591 | 21,667 | |||
| Total | 135 | 72,605 | 72,740 | 84 | 23,448 | 23,532 | |||
| Total | SD | 13 | 7413 | 7426 | 0.751 (0.427–1.322) | 15 | 2586 | 2601 | 1.304 (0.759–2.238) |
| MD | 164 | 70,256 | 70,420 | 112 | 25,174 | 25,286 | |||
| Total | 177 | 77,669 | 77,846 | 127 | 27,760 | 27,887 | |||
aIn this paper, data are not presented separately for total knee and total hip replacements
OR Odds Ratio, CI confidence interval, SD single-dose, MD multiple-dose
Discussion
In the majority of the selected papers [11, 13, 14], a follow-up period of 1 year after prosthesis implantation has been chosen, as it is considered that in a longer follow-up, the influence of hematogenous infection on total infections could be greater than the influence of antibiotic prophylaxis at surgery [11].
The pathogens most commonly associated with surgical-site infections are Staphylococcus Aureus and Staphylococcus Epidermidis. Consequently, antibiotic prophylaxis is typically directed against gram-positive bacteria [12]. In the papers included in this work, different antibiotics are used: cefazolin and cefuroxime [11, 14]; flucloxacillin, teicoplanin, and gentamicin [12]; cefazolin and vancomycin [13]. When interpreting the results of the meta-analysis, it should be taken into account that the different antibiotic regimens were grouped into single and multiple doses (it is assumed that the choice of each antibiotic was made according to the microorganism and resistance profile of each hospital or area and that it was correct for its endemic flora). In single-dose prophylaxis, cefazolin has been the most commonly used antibiotic in these studies [11, 13, 14]. Of the antibiotics studied in multiple doses, cefazolin and cefuroxime have been the most prevalent [11, 13, 14]. This choice of antibiotherapy is in line with most practice guidelines and consensus articles [5–8]. Among the papers included in the present review, Babu et al. were the only authors to include study groups with prophylaxis with more than one antibiotic in both single and multiple doses [12]. They defend the importance of coverage against multi-resistant organisms (methicillin-resistant Staphylococcus Aureus (MRSA) or Clostridium Difficile). The combination of cefuroxime, flucoxacillin or teicoplanin with gentamicin in the different study groups has been shown to have no overall impact on infection rates [12]. However, these combinations may be recommended for high-risk patients [5].
Despite the use of antiseptic measures and prophylactic antibiotic therapy, reports from knee arthroplasty series indicate an infection rate between 0.24% and 1.6% [4, 11–16]. The results presented in the studies included in this review are in line with those described in the literature, with no further infections observed in the groups in which a single-dose of prophylactic antibiotic [11, 13, 14]. The highest infection rate was observed in the study by Tang et al. [14], with 1.6% (8 patients) in the group receiving multiple doses of cefuroxime and 2 patients (1.01%) in the group receiving a single dose of cefuroxime. Second, Babu et al. [12] report an infection rate of 1.19% for the single-dose flucloxacillin + gentamicin group (9 patients). The single-dose teicoplanin + gentamicin group had a slightly lower rate (0.97%, 8 patients). Veltman et al. present the series with the largest number of patients (9880), but the lowest infection rate, with 303 patients experiencing an infection [11]. In light of the antibiotic regimen employed, the infections were distributed across the groups as follows: 260 received multiple doses of cefazolin (0.27% infection), 19 multiple doses of cefuroxime (0.4% infection) and 24 received a single dose of cefazolin, the latter group having the lowest infection rate among the selected studies with 0.24% [11]. In this study, a higher percentage of infections was observed in patients who received multiple doses of cefuroxime; in patients who received cefazolin prophylaxis, the infection rate was slightly higher using multiple doses than single doses [11]. The paper by Tan et al. [13] shows an infection rate of 0.88% for the group given multiple doses of cefazolin or vancomycin and 0.60% for the group given single doses of cefazolin or vancomycin. However, these data refer to the knee and hip together, as this paper also includes the hip joint and does not break down the specific infection rate by joint. Therefore, based on the results of these studies, prophylaxis in total knee arthroplasty with single-dose cefazolin monotherapy is not inferior to the use of multiple doses or more than one antibiotic (single or multiple doses) [11–14].
Patients who received a single dose of antibiotic prophylaxis showed a lower risk of prosthetic joint infections compared to those who received multiple doses. However, this difference was not statistically significant (p = 0.57) (Fig. 3). This is consistent with the separate conclusions of the authors of the 4 papers included in this systematic review, who conclude that they find no statistically significant differences with the different antibiotic prophylaxis regimens used in total knee arthroplasty [11–14], thus suggesting that there is no rationale for using multiple doses rather than a single dose [11, 13], as recommended for pragmatic reasons (adjusted for local pathogens) [12]. Furthermore, Tang et al. suggest that the optimal duration of antibiotic prophylaxis should be as brief as possible to minimize the risk of resistance, enhance adherence to treatment and reduce both pharmacological and personal costs [14]. Similarly, in a recent review of primary knee and hip arthroplasty, Fernandes et al. found that single-dose antibiotic prophylaxis protocols offered a higher risk–benefit ratio than multi-dose protocols and recommended the use of single-dose antibiotic prophylaxis in these procedures [17]. In contrast, some authors suggest that while they agree with the use of single-dose antibiotics in healthy, low-risk patients, the use of longer regimens should be considered in patients with risk factors for infection [13, 18]. Veltman et al. calculated the hazard ratio adjusted for age, sex, body mass index and ASA grade and found no change in the risk of complete revision for infection [11]. Babu et al. reported that patients’ ASA scores, tourniquet times and proportion of smokers/diabetics were similar between the different antibiotic regimen groups [12]. Tan et al., using a multivariate logistic regression analysis, found that potential confounders (diabetes, smoking, obesity, rheumatoid arthritis, psychosis, liver disease, renal disease, HIV/AIDS) did not modify the prosthesis infection rate in both single and multiple-dose antibiotic groups [13]. Finally, Tang et al. reported no data on the influence of potential confounders on the risk of prosthesis infection [14]. The paucity of data on confounding factors and the differences between the studies in terms of the confounding data examined and how they were measured make it difficult to compare the results of the 4 studies or to present a combined quantitative analysis. Despite these difficulties, the present study performed a pooled quantitative analysis of the influence of sex (female) and obesity based on the data provided by Veltman et al. [11] and Tan et al. [13]. With the limitation that the Tan study does not present these data separately for total knee and total hip arthroplasty, together these potential confounders (female sex and obesity) did not significantly alter the risk of prosthesis infection in the single- and multiple-dose antibiotic groups.
One of the limitations encountered when conducting the literature search for this systematic review was that several studies that included information on knee and hip arthroplasty did not report results separated by type of arthroplasty and could not be included in this work [4, 15, 16], but they also did not find a benefit in multiple-dose versus single-dose protocols. This has led to only four studies being included in this review, which may limit the strength of the evidence and the generalizability of the findings. The lack of more systematic investigation of possible risk factors or comorbidities that may influence prosthesis infection could be a confounding factor and should be considered independently when selecting the antibiotic prophylaxis regimen for each individual patient. When interpreting the results, it is also important to take into account the different antibiotic regimens used in the included studies.
Conclusions
The use of multiple-dose antibiotic prophylaxis in total knee arthroplasty has not been shown to be more effective in reducing infections and other complications than single-dose antibiotic prophylaxis. This systematic review has not identified any strong scientific or clinical evidence to justify the routine use of multiple-dose antibiotic prophylaxis in knee arthroplasty surgery.
Acknowledgements
The authors would like to thank Dr Vannina G Marrachelli for her assistance with the statistical analysis.
Funding
No public or private funding has been received for this work.
Data availability
Not applicable.
Declarations
Conflict of interest
The authors declare that they have no conflict of interest.
Ethical standard statement
This article does not contain any studies with human or animal subjects performed by any of the authors.
Informed consent
For this type of study informed consent is not required.
Registration
The systematic review protocol has not been preregistered or prepublished.
Footnotes
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Data Availability Statement
Not applicable.