Abstract
Autologous bone grafts (autografts) are used in surgery for defect filling and impaction grafting during hip socket and femur reconstruction. Because of their superior osteoinductive capacity, autografts are considered the "gold standard" for these treatments. However, because of abetter cost-benefit ratio, allografts are also often used. In the case of limited donor availability for autologous or allogenic bone grafts, bone substitute materials (BSMs) are areasonable alternative or supplement. BSM are based on or combine different substances. Growth factors of the bone morphogenetic protein family BMP are recombinant proteins that specifically induce the growth of bone and cartilage tissue. One advantage of BSM is the option to combine them with several anti-infective agents. The choice of the anti-infective substance should not only be based on the antimicrobial efficacy, but should also take into account possible dose-dependent cellular and pharmacological side effects at the implantation site. Thus, microbiologists, pharmacists and surgeons should decide together which combination is the most appropriate. BSM with active agent additives are considered combination products that are characterized by amain effect (bone replacement function) and asecondary effect (prophylaxis of bacterial recolonization of BSM). Both functions must be thoroughly (clinically) evidenced in the course of the registration process as aclassIII medical device. Drug authorities evaluate the active agents, their function and corresponding indication. Currently, only afew combination products are available on the market. As aconsequence of the only limited availability of such commercial combination products, surgeons in clinical practice often manually add the active agent to BSM in the theatre prior to implantation. However, such acustomized addition of antibiotics places the surgeon in asituation of a manufacturer where he assumes liability for the product.
Highlights
Autologous bone grafts are used in surgery for defect filling and impaction grafting during hip socket and femur reconstruction
Growth factors of the bone morphogenetic protein family BMP are recombinant proteins that induce the growth of bone and cartilage tissue
Die Ausrüstung von KEW mit antiinfektiven Substanzen ist in der Regel bedeutend einfacher als die von Knochenchips, da KEW entweder als trockene Pulver oder Granulate zum Einsatz kommen, die während der Herstellung elegant mit antiinfektiven Substanzen versetzt werden können
Summary
Autogenes Knochenmaterial gilt immer noch als Goldstandard. Ist allerdings Knochenmaterial nicht ausreichend vorhanden, kommen Knochenersatzwerkstoffe zum Einsatz. Pfannen- [72] und Femurrekonstruktionen mittels der Technik des Impaction Grafting [31] können in Bezug auf Infektionen kritisch sein, da bei der erneuten Operation der knöcherne Unterbau sowie zusätzliches Knochenmaterial entfernt werden muss. In klinischen Fällen, in denen Knochenzemente mit Antibiotika nicht indiziert sind, wurde frühzeitig versucht, Knochenchips mit oder ohne Knochenersatzwerkstoffe (KEW) zusätzlich mit antiinfektivenWirkstoffenzu versehen, und das Kombinationsmaterial als lokalen Wirkstoffträger klinisch zu verwenden [9, 29]. Obwohl es sich in der Regel bei den KEW um Medizinprodukte handelt, steht bei einer zusätzlichen Wirkstoffzugabe oftmals die Nebenfunktion klinisch im Vordergrund – das Débridement mit systemischer und lokaler Antibiotikagabe: 4 Systemische Antibiotikagabe: jProphylaxe hämatogen streuender Keime, jTherapie: gezielte Gabe (Dosis) von Antibiotika.
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