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Antibiotic Infused Bone Cement for Orthopedic Surgeries: a Review of the Clinical Benefit and Harm

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Antibiotic Infused Bone Cement for Orthopedic Surgeries: a Review of the Clinical Benefit and Harm TITLE: Antibiotic Infused Bone Cement for Orthopedic Surgeries: A Review of the Clinical Benefit and Harm DATE: 17 November 2008 CONTEXT AND POLICY ISSUES: Infection is a serious complication following prosthetic joint replacement. The rate of infection is less than 1% after hip or shoulder replacement and less than 2% in knee replacement surgery.1 Surgical treatment for infected joint prosthesis include debridement with retention of the prosthesis, one- or two-stage exchange, resection arthroplasty (removal of joint without replacement), arthrodesis (fusion of the joint), or amputation.1 In a one-stage exchange revision, the infected joint is removed and a new joint implanted in the same surgery. In the two-stage procedure, a delay of several weeks occurs between removal and replacement of the joint. Antibiotic loaded cement spacer or beads may be inserted into the joint space in the interim.1 In North America, the two-stage revision procedure is more common than the one-stage.1 Antibiotic-loaded bone cement may be used to prevent infection in primary joint replacement, and as part of the treatment of infected joints.2 Prophylactic use of low concentration antibiotic cement is common in some European countries despite concerns that antibiotic bone cement may induce local and systemic toxicity, allergy, and lead to the development of drug-resistant bacteria.3 The commercially available antibiotic bone cement products have ≤ 1 g of antibiotic per bag of cement.3 Higher doses of antibiotic used for infected joints require hand mixing of antibiotic powder with the bone cement.2 The drug elution characteristics can vary depending on the type of antibiotic and cement, and the mixing conditions.3 The mechanical strength of the cement is also affected by the concentration of antibiotic.3 Information on the potential benefits and harms of antibiotic-loaded bone cement is required to inform healthcare manager’s purchasing decisions. Disclaimer: The Health Technology Inquiry Service (HTIS) is an information service for those involved in planning and providing health care in Canada. HTIS responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources and a summary of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. HTIS responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material. It may be copied and used for non-commercial purposes, provided that attribution is given to CADTH. Links: This report may contain links to other information on available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners’ own terms and conditions. 1 RESEARCH QUESTION: What is the evidence for the clinical benefit and harm of antibiotic infused bone cement for use in orthopedic surgeries? METHODS: A limited literature search was conducted on key health technology assessment resources, including OVID MedLine, OVID Embase, The Cochrane Library (Issue 4, 2008), University of York Centre for Reviews and Dissemination (CRD) databases, ECRI, EuroScan, international health technology agencies, and a focused Internet search. Results include articles published between 2003 and October 2008, and are limited to English language publications only. No filters were applied to limit the retrieval by study type for the MedLine search. Filters were applied to limit retrieval to systematic reviews, health technology assessments, meta-analyses, randomized controlled trials and guidelines for the Embase search. The bibliographies of relevant articles were also searched. HTIS reports are organized so that the higher quality evidence is presented first. Therefore, health technology assessment reports, systematic reviews, and meta-analyses are presented first. These are followed by randomized controlled trials (RCTs) and observational studies. SUMMARY OF FINDINGS: Health technology assessments No relevant health technology assessments were identified in the search. Systematic reviews and meta-analyses Two systematic reviews and one meta-analysis were identified evaluating the use of antibiotic bone cement for primary joint arthroplasty.4-6 In the meta-analysis, discrepancies were noted between the text and the figures, and it appeared as though multiple outcomes for the same group of patients were included in the pooled effect estimates. The results of this study were not considered reliable and thus were not summarized.4 No systematic reviews or meta-analyses were identified for revision arthroplasty in infected joints. Characteristics of the systematic reviews are summarized in Appendix 1, Tables A1 and A2. The systematic review by AlBuhairan et al.5 assessed antibiotic prophylaxis for the prevention of wound infections following total joint arthroplasty. The authors included RCTs in patients undergoing primary or revision hip or knee replacement. Three RCTs were identified that compared the use of systemic antibiotics to antibiotic-impregnated bone cement (n=2388) (Josefsson 1993, McQueen 1987, McQueen 1990). No significant difference was detected between treatments with a pooled relative risk of 0.88 [95% CI 0.59 to 1.31, p=0.52]. The systematic review by Block and Stubbs6 included both randomized and non-randomized trials that evaluated the use of antibiotic bone cement in patients undergoing primary hip or knee arthroplasty. Comparators included plain bone cement or systemic antibiotic prophylaxis. Nine RCTs, 10 cohort studies, one case-control study, and two case series were included. A narrative synthesis of results was conducted without meta-analysis. Antibiotic Bone Cement for Orthopedic Surgeries 2 In the included RCTs, the frequency of deep infection ranged from 0% to 1.1% and 0% and 13.5% in the antibiotic cement and control groups respectively (Appendix 1, Table A2). In four reports, the difference between groups was not statistically significant (Pfarr 1977, Josefsson 1993, McQueen 1987, McQueen 1990). In the other five reports, antibiotic cement was associated with a statistically significant reduction in the frequency of deep infections (Wannske 1979, Josefsson 1981, Josefsson 1990, Chiu 2001, Chiu 2002).6 The largest RCT by Josefsson et al. compared gentamicin bone cement to systemic antibiotic prophylaxis in 1599 patients (1688 hips). The follow-up data after 2, 5 and 10 years was described in three published reports (Josefsson 1981, Josefsson 1990, Josefsson 1993). All three papers reported a lower frequency of deep infection among patients treated with antibiotic cement compared to the control group. After 2 and 5 years of follow up, these differences were statistically significant. In the 10 year analysis, some patients were reclassified and the difference in deep infection frequency between antibiotic bone cement and control was no longer statistically significant (1.1% and 1.6% respectively).6 The frequency of aseptic loosening of the joint was significantly lower in the one RCT (Josefsson 1981) reporting this outcome (1.6% versus 3.3% in the cement and control groups respectively, p=0.03). Aseptic loosening may be attributed in part to subclinical infection.6 Block and Stubbs6 summarized one case control and 10 cohort studies, three of which included some of the same patients. The frequency of deep infection was lower in patients treated with antibiotic cement (range 0.2% to 1.6%) compared to control (range 0.4% to 6.2%). A registry of over 90,000 primary hip arthroplasties in Sweden showed antibiotic bone cement provided a significant reduction in the risk of revision due to deep infection adjusted for other protective factors. A Norwegian registry of over 10,000 hip arthroplasties showed the infection related revision rate was similar between patients who received systemic antibiotics compared to antibiotic cement, after adjusting for confounders. Combined systemic antibiotics and antibiotic cement was better than either intervention alone, or plain bone cement (p<0.003). Randomized controlled trials One relevant RCT was published within the last five years.7 In this study, patients with infected hip arthroplasty were enrolled and underwent a two stage revision procedure (n=68). Patients in the treatment group had an antibiotic cement spacer inserted after removal of the infected joint. In the control group, no spacer was inserted and the patients remained in hospital under traction until the infection was cured and the second artificial joint was inserted. Both patient groups were treated with oral and intravenous antibiotics between the first and second stage surgeries. The
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