Choice and doses of antibacterial agents for cement spacers in treatment of prosthetic joint infections: review of published studies.
BACKGROUND
Addition of antibacterial drugs to interim antibacterial cement spacers (ACSs) is considered to be standard of care for surgical revision in prosthetic joint infections (PJIs). We reviewed published studies evaluating the choice and doses of antibacterials in spacers.


METHODS
We conducted a PubMed search of all clinical study reports evaluating the use of ACSS in a 2-stage hip or knee arthroplasty for treatment of PJI (1988 through August 2011). The trial design, antibacterials used, and end points studied were analyzed.


RESULTS
No randomized trials were found comparing either ACSs with different concentrations of antibacterials or ACSs with or without antibacterials. Most of the studies were uncontrolled and used various time points to evaluate the outcome. Twenty publications that reported doses of antibacterials in spacers and had a follow-up of ≥ 24 months after the second stage were selected for review. Most ACSs included vancomycin and aminoglycosides. The doses of aminoglycosides and vancomycin ranged from 0.25 to 4.8 g and from 1 to 4 g, respectively, per 4 g of cement. No association between reported eradication of the infection and antibacterial load was found.


CONCLUSIONS
Published data do not allow evaluation of whether antibacterials in temporary cement spacers provide additional benefits in the treatment of PJI, compared with systemic antibacterials, and are not sufficient to support recommendations on dosages. Complications of ACSs have not been consistently analyzed. Prospective randomized trials comparing spacers with and without antibacterials or spacers with different loads of antibacterials are needed to evaluate the safety and efficacy of ACSs.
Center for Drug Evaluation and Research, Office of New Drugs, Division of Anti-Infective Products, US Food and Drug Administration, Silver Spring, Maryland. dmitri.iarikov@fda.hhs.gov
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Iarikov
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Rubin
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Alexander
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D000617:Aminoglycosides / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001843:Bone Cements / Q000032:analysis*; D006801:Humans; D016459:Prosthesis-Related Infections / Q000188:drug therapy*; D014640:Vancomycin / Q000627:therapeutic use*
D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D001843:Bone Cements; D014640:Vancomycin