Antibiotic-loaded bone cement and its widespread use: is it justified? (original) (raw)

Routine use of commercial antibiotic-loaded bone cement in primary total joint arthroplasty: a critical analysis of the current evidence

Antibiotic-loaded cement (ABLC) has been widely utilized as an adjuvant treatment for patients with periprosthetic joint infection (PJI) but has also evolved to play a prophylactic role against infection in primary total joint arthroplasties (TJA). Nevertheless, there is currently a paucity of studies that systematically investigated this concept. This review aimed at answering the following questions: (I) Can routine use of ABLC help reduce the current infection rates in primary TJA? (II) What are the risks associated with this approach? And (III) can routine use be justified in primary TJA from an economic standpoint? Multiple databases were queried including PubMed, EMBASE, EBSCO Host, and SCOPUS. Studies published between January 1, 1990 and March 31, 2018 were reviewed. Inclusion criteria were studies reporting: (I) clinical outcomes of routine use of ABLC in primary hip and knee arthroplasty with 2-year minimum follow-up, (II) complications related to the use of ABLC, (III) cost of using ABLC. The final analysis included 24 studies. Data from multiple studies demonstrate contradictory results for infection rates when ABLC is used in all primary procedures with a majority of studies showing similar infection rates between ABLC and plain cement. The main concerns associated with routine use of ABLC are negative effects on the mechanical stability of cement, possible systemic and local toxicity of the absorbed antibiotic, and development of resistant bacterial strains. However, current literature has not clinically validated these concerns. Lastly, with an estimated increase in 117 million dollars with the routine use of ABLC in only 50% of TJAs performed each year, it is difficult to justify the use of ABLC without clear superiority in reducing infection. The use of ABLC has undeniably changed the way orthopaedic surgeons deal with PJI today. However, the large-scale, prophylactic use of ABLC in primary TJAs requires further research and justification.

Prophylactic use of antibiotic-loaded bone cement in primary total knee arthroplasty: Justified or not?

Indian Journal of Orthopaedics, 2009

Background: The routine use of antibiotic-loaded bone cement (ABLC) during primary or uninfected revision arthroplasty remains controversial. Many studies quote the total joint arthroplasty (TJA) infection rate to be less than 1%. Total knee arthroplasty (TKA) has a higher infection rate than total hip arthroplasty (THA). Based on both animal and human studies in the past, ABLC has been found effective in reducing the risk of infection in primary TJA. We are presenting retrospective analysis of results in terms of infection rate in 659 TKA performed by a single surgeon under similar conditions during 2004-2007 using CMW1 (Depuy, Leeds, UK) with premixed 1 g of gentamicin. Patients and Methods: We did primary TKA in 659 knees of 379 patients during 2004-2007 using CMW1 (Depuy, Leeds, UK) cement containing 1 g of gentamicin in 40 g of cement in a premixed form. Standard OT conditions were maintained using laminar air flow, isolation suits for the operating team, pulse lavage and disposable drapes in each patients. Midvastus approach was used in all the patients to expose the knee joint. A systemic antibiotic (third-generation cephalosporin and aminoglycoside) was used preoperatively and 48 h postoperatively. We observed the patients in terms of infection in the high-risk and low-risk group till the recent follow-up with a mean of 20.6 months (9-38 months). Results: We had deep infection in six knees in six patients and all of them required two-stage revision surgery later in the highrisk group. Infection occurred at a mean of 20.5 months after surgery earliest at 9 months and latest at 36 months after surgery. The infection rate in our study was 0.91% which is comparatively less than the reported incidence of 1-2% in reported studies. Conclusion: We conclude that the use of antibiotic loaded bone cement is one of the effective means in preventing infection in primary TJA.

Antibiotic containing bone cement in prevention of hip and knee prosthetic joint infections: A systematic review and meta-analysis

Journal of Orthopaedic Translation

Background: Prosthetic joint infection (PJI) is the most serious total joint arthroplasty (TJA) complication despite several aseptic and antiseptic preventive measures. There is no clear evidence or even consensus, whether antibiotic-loaded bone cement (ALBC) should be used, in addition to systemic short-term routine antibiotic prophylaxis, to reduce the risk of PJI in primary TJA. We aimed to analyze the efficacy of ALBC for prevention of PJI in patients undergoing primary TJA. Methods: We searched systematically for randomized controlled trials (RCTs) in PubMed, Scopus, Embase, Web of Science and Cochrane library. Two reviewers independently screened potentially eligible studies according to predefined selection criteria and assessed the risk of bias using a modified version of the Cochrane risk of bias tool. PJI was prespecified as the primary outcome of interest. The meta-analyses were based on risk ratios using random-effects model per default. For the purpose of sensitivity, the corresponding fixed effects model odds ratios were calculated with the use of the Peto method as well. To evaluate a potential difference in effect sizes using different types (subgroups) of antibiotics used in bone cement, and at different follow-up periods, we performed stratified meta-analyses. Results: Thirty-seven studies were eligible for the systematic review and qualitative synthesis, and 9 trials (6507 total joint arthroplasties) were included in this meta-analysis. Overall ALBC significantly reduced the risk of PJI following primary TJAs (RRs, 0.36; 95% CIs, 0.16 to 0.80; P ¼ 0.01) with a moderate degree of inconsistency (I 2 ¼ 47%). Based on stratified meta-analyses the use of gentamicin appeared to have a better effect (P ¼ 0.0005) in the total hip arthroplasty. Pooled data of different antibiotics used in knee arthroplasties showed a significant association of cefuroxime (RRs, 0.08; 95% CIs, 0.01 to 0.63; P ¼ 0.02). Further, ALBCs significantly reduced the PJI at one and two years of follow-up (P ¼ 0.03 and P ¼ 0.005 respectively). Conclusions: The evidence suggests that ALBCs are effective in reducing the PJI following primary TJA; i.e. between 20 and 84% reduced risk. However, the clear limitations of the available trial evidence highlight the need for joint-specific confirmatory trials, that will need to be designed as cluster-randomized trials of clinics in countries with well-functioning arthroplasty registries. The translational potential of this article: This meta-analysis highlights the prophylactic potential of ALBCs in lowering the risk of infection following primary hip or knee arthroplasties but emphasizes the need for more recent confirmatory trials.

The use of antibiotic-loaded bone cement and systemic antibiotic prophylactic use in 2,971,357 primary total knee arthroplasties from 2010 to 2020: an international register-based observational study among countries in Africa, Europe, North America, and Oceania

Acta Orthopaedica

Background and purpose: Antibiotic-loaded bone cement (ALBC) and systemic antibiotic prophylaxis (SAP) have been used to reduce periprosthetic joint infection (PJI) rates. We investigated the use of ALBC and SAP in primary total knee arthroplasty (TKA).Patients and methods: This observational study is based on 2,971,357 primary TKAs reported in 2010–2020 to national/regional joint arthroplasty registries in Australia, Denmark, Finland, Germany, Italy, the Netherlands, New Zealand, Norway, Romania, South Africa, Sweden, Switzerland, the UK, and the USA. Aggregate-level data on trends and types of bone cement, antibiotic agents, and doses and duration of SAP used was extracted from participating registries.Results: ALBC was used in 77% of the TKAs with variation ranging from 100% in Norway to 31% in the USA. Palacos R+G was the most common (62%) ALBC type used. The primary antibiotic used in ALBC was gentamicin (94%). Use of ALBC in combination with SAP was common practice (77%). Cefa...

Antibiotic-Loaded Bone Cement in Prevention of Periprosthetic Joint Infections in Primary Total Knee Arthroplasty: A Register-based Multicentre Randomised Controlled Non-inferiority Trial (ALBA trial)

BMJ Open

IntroductionThe current evidence on the efficacy of antibiotic-loaded bone cement (ALBC) in reducing the risk of periprosthetic joint infections (PJI) after primary joint reconstruction is insufficient. In several European countries, the use of ALBC is routine practice unlike in the USA where ALBC use is not approved in low-risk patients. Therefore, we designed a double-blinded pragmatic multicentre register-based randomised controlled non-inferiority trial to investigate the effects of ALBC compared with plain bone cement in primary total knee arthroplasty (TKA).Methods and analysisA minimum of 9,172 patients undergoing full-cemented primary TKA will be recruited and equally randomised into the ALBC group and the plain bone cement group. This trial will be conducted in Norwegian hospitals that routinely perform cemented primary TKA. The primary outcome will be risk of revision surgery due to PJI at 1-year of follow-up. Secondary outcomes will be: risk of revision due to any reason ...

Hip and Knee Section, Prevention, Local Antimicrobials: Proceedings of International Consensus on Orthopedic Infections

The Journal of arthroplasty, 2018

primary joint arthroplasty antibiotic-impregnated cement antibiotic cement dosage total hip replacement total knee replacement surgical site infection (SSI) risk periprosthetic joint infection (PJI) risk Question 1: Is there sufficient evidence to support the use of antibiotic-loaded cement in primary TKA or THA to reduce the risk of surgical site infections/periprosthetic joint infections (SSIs/PJIs)? Recommendation: There is no conclusive evidence to demonstrate that routine use of antibiotic-loaded cement in primary TKA or THA reduces the risk of subsequent surgical site infections/periprosthetic joint infections (SSIs/PJIs). Recent high-level evidence and registry data have not demonstrated a reduction in SSI/PJI. Furthermore, the added cost, the potential for the emergence of resistant organisms, and the potential adverse effect of antibiotics on the host provide adequate reasons to refrain from the routine use of antibiotic-loaded cement during primary total joint arthroplasty.

Antibiotic bone cement's effect on infection rates in primary and revision total knee arthroplasties

World journal of orthopedics, 2017

To compare infection rates in primary and revision total knee arthroplasty (TKA) procedures using antibiotic impregnated bone cement (AIBC) to those rates in procedures not using AIBC. A systematic review and meta-analysis was conducted in search for randomized controlled trials/studies (RCTs) pertaining to the field of antibiotic AIBC non-AIBC groups in both primary and revision TKA procedures. The primary literature search performed was to identify all RCTs that assessed AIBC in primary and revision TKA procedures. This search was done strictly through the PubMed database using the article "filters" setting that identified and separated all RCTs from the overall search. The original search was "Primary/revision total knee arthroplasty using AIBC". Other key terms and phrases were included in the search as well. Eligible articles that were used in the "results" of this review met the following criteria: (1) Involved primary or revision TKA procedures (...

Perioperative Antibiotic Prophylaxis in Total Joint Arthroplasty

Infected Total Joint Arthroplasty, 2012

Background: The 2017 U.S. Centers for Disease Control and Prevention (CDC) guidelines for the prevention of surgical site infection (SSI) recommended against continuation of antibiotics postoperatively after total joint arthroplasty. This is disconcerting, as the revised guidelines are based on only 6 orthopaedic studies, of which 83% (5 of 6) were published from 1987 to 1991. The purpose of the current study was to conduct a systematic review and meta-analysis of the literature regarding the efficacy and duration of surgical antibiotic prophylaxis (SAP) in total joint arthroplasty. Methods: PubMed, Ovid MEDLINE, and Ovid Embase were screened for "surgical antimicrobial prophylaxis orthopedic," in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, without a specified time frame with respect to publication date. A total of 693 studies were screened, and 32 studies were evaluated. Data were extracted regarding antibiotic type, number of doses, and duration. Prospective and retrospective studies examining perioperative antibiotics with subsequent SSI and periprosthetic joint infection (PJI) rates in total joint arthroplasty were included. Results: Twenty-three randomized controlled trials (RCTs) and 2 prospective cohort, 3 retrospective cohort, and 4 casecontrol studies with a total of 51,627 patients were included in this review. The overall pooled effect for the comparison between a single preoperative dose of antibiotic and continued (preoperative plus postoperative) administration was 0.96 (95% confidence interval [CI], 0.73 to 1.26), suggesting no difference in effect. However, the 95% CI for the relative risk would include a reduction of approximately 27% in either group. The overall pooled effect from the comparison between SAP of £24 and >24 hours postoperatively demonstrated no difference in effect. All included studies were underpowered and heterogenous regarding type of antibiotic used and duration. Conclusions: Our review confirms the benefit of SAP utilization in total joint arthroplasty. The available evidence does not show added benefit of postoperative SAP or continuation beyond 24 hours. However, the overall GRADE (Grading of Recommendations Assessment, Development and Evaluation) of evidence of the available literature was low (high risk of bias, high risk of publication bias, and low precision). The findings of this study demonstrate the need for Level-I studies with adequate power to evaluate the safety of shortened SAP duration after total joint arthroplasty and its effect on SSI/PJI prior to widespread implementation. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence. S urgical site infection (SSI), also known as periprosthetic joint infection (PJI) after total joint arthroplasty, is one of the most severe complications and is associated with prolonged morbidity and mortality, disability, and increased costs 1-8. Prophylactic antibiotic use in arthroplasty to prevent infection was the "gold standard" before the U.S. Centers for Disease Control and Prevention (CDC) guidelines 9,10. In 1999, the CDC published guidelines recommending perioperative antibiotic prophylaxis to reduce the occurrence of SSIs. Several years later, the CDC joined the U.S. Centers for Medicare & Medicaid Services (CMS) to create the Surgical Care Improvement Project (SCIP 2006), which highlighted the importance of perioperative antibiotic administration within 2 hours of incision 11. Disclosure: The authors indicated that no external funding was received for any aspect of this work. On the Disclosure of Potential Conflicts of Interest forms, which are provided with the online version of the article, one or more of the authors checked "yes" to indicate that the author had a relevant financial relationship in the biomedical arena outside the submitted work (http://links.lww.com/JBJS/F209).