CERAMENT G and V
CERAMENT G is an injectable synthetic bone void filler consisting of 40% hydroxyapatite, 60% calcium sulfate and the antibiotic gentamicin sulfate. This unique ratio of hydroxyapatite and calcium sulfate is designed to enable CERAMENT to resorb at the same rate that bone forms. Calcium sulfate acts as a resorbable carrier for hydroxyapatite, and hydroxyapatite is highly osteoconductive, promoting bone ingrowth. The addition of gentamicin protects against colonization by gentamicin-sensitive microorganisms. CERAMENT V contains the antibiotic vancomycin, and has the same mode of action but protects against colonization by vancomycin-sensitive microorganisms.
Remodeling into bone within 6-12 months
With CERAMENT, simultaneous de novo bone formation is seen throughout the material and it is fully remodeled into host bone within 6-12 months.1,4,9 Rapid bone remodeling reduces the risk of fracture, non-union and (re)infection.2-4, 10
Injectable and flowable
CERAMENT can be injected through a 16G needle, making it ideal for minimally invasive procedures. Flowability ensures excellent spread into and around a bone defect, for complete dead space management. This is particularly important for the healing of complex defects, where the extent of bone loss may not be apparent at first and certain areas may be difficult to access.
Antibiotic elution above MIC that is reliable and consistent
To protect the CERAMENT implant from bacterial colonization, it is essential to have a high initial concentration of antibiotic to deliver the most effective bactericidal blow to the pathogens that could cause a bone infection and to maintain the antibiotic concentration above MIC levels for a clinically relevant period of time (>28 days). In vitro and in vivo data have proven that CERAMENT G and V provide high local concentrations of antibiotic above MIC, and elute antibiotic for 20-30 days.11-14
High local concentration of gentamicin, without high serum gentamicin
CERAMENT G and CERAMENT V have been designed to offer high local concentrations of gentamicin or vancomycin to effectively protect bone healing from gentamicin or vancomycin-sensitive organisms.
The high local concentration of gentamicin or vancomycin is safe.11-14
In vitro studies have shown that CERAMENT V offers vancomycin levels up to 3,000 times the minimum inhibitory concentration (MIC) for Methicillin-Resistant Staphylococcus aureus (MRSA).13-15
In vivo studies have shown that CERAMENT G offers local gentamicin concentration levels 64-150 times higher than the minimum inhibitory concentration (MIC) for gentamicin-sensitive pathogens such as Staphylococcus aureus and Pseudomonas aeruginosa.11,12,15
In clinical assessment in patients with long bone osteomyelitis treated with up to 30 mL CERAMENT G (mean volume of 11.6 mL injected), the highest reported serum concentration of gentamicin was < 2 mg/mL within 24 hours after surgery, well below the gentamicin serum toxicity threshold level of 12 mg/mL.11 Patients who underwent tumor resection arthroplasty with CERAMENT V implanted into the bone void, showed a mean concentration of vancomycin in blood plasma of 0.3µg/mL (range 0.0 – 1.6µg/mL), well below the trough toxicity level of 10-20 µg/mL.13