Self-mixed antibiotic bone cement: western countries learn from developing countries

Open Access-This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the source is credited. The paper of Rasyid et al. (2009) in this issue of Acta Ortho-paedica addresses a problem that is important for those who treat bone and joint infections in developing countries, but increasingly also in so-called western countries. The paper is interesting and helpful for all surgeons who have to make antibiotic-loaded beads and spacers by themselves. This is necessary when commercially produced bone cement and beads are not available, or when the antibiotic in the PMMA is not effective due to resistance of the causative bacteria. The paper is based on a recent thesis from the research group of the Department of Biomedical Engineering at the University of Groningen, and is part of a series of publications about basic and clinical research on antibiotic-loaded cement and other biomaterials (When gentamicin-loaded bone cement (Refobacin-Palacos) became available in Germany in the 1970s, efforts to treat osteomyelitis by filling the debrided cavity with solid plugs of antibiotic-loaded bone cement were not successful in patients in France and Germany, nor in animal experiments in the started to make handmade beads in his infection unit in the BG Unfallklinik in Frankfurt (Klemm 1993). The argument at that time for developing beads instead of solid cement plugs was that the debrided osteomyelitic cavities had to secrete freely—and it was not the increase in surface area-volume ratio, as is the accepted explanation for improved effectiveness nowadays. The Kulzer company (Wehrheim, Germany), the producer of Refobacin-Palacos, developed the production of gentamicin-PMMA beads (Septopal) in the seventies. Sep-topal beads have now been on the market for more then 30 years, a remarkably long time for a pharmacological product. This shows that the gentamicin-PMMA beads are still a unique product; they are needed in clinical practice and there is no good alternative when there is a requirement for local antibiotic treatment. Over the first 25 years, Septopal was distributed in most countries of Europe by Merck (Darmstadt, Germany), and nowadays it is distributed by Biomet (Biomet Europe, Berlin, Germany). It is still not accepted by the FDA in the US. One of the arguments against the use of antibiotic-loaded beads is the lack of proof of effectivity in good randomized clinical trials (RCTs). The most cited RCT was performed …