CERAMENT® G

CERAMENT G is an injectable synthetic bone void filler consisting of 40% hydroxyapatite, 60% calcium sulfate and the antibiotic gentamicin sulfate.

The 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.

The characteristics of CERAMENT G mean that surgeons can manage bone defects in a more patient-friendly single-stage procedure. CERAMENT G has proven clinical outcomes, with one of the lowest (re)fracture and (re)infection rates of any synthetic bone substitute on the market. Moving to a single-stage from a multi-stage surgical protocol also frees healthcare resources to meet other needs, paving the way for a more cost-effective strategy for hospitals.

Remodels into host 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. Rapid bone remodeling reduces the risk of fracture, non-union and (re)infection.

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.

Gentamicin 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 gentamicin to deliver the most effective bactericidal blow to the pathogens that could cause a bone infection and to maintain the gentamicin concentration above MIC levels for a clinically relevant period of time (>28 days).

High local concentration of gentamicin, without high serum gentamicin levels

CERAMENT G has been designed to offer high local concentrations of gentamicin to effectively protect bone healing from gentamicin-sensitive organisms.

The high local concentration of gentamicin is safe. 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.

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

REFERENZEN

REFERENCES for introduction text
CERAMENT® G Instructions for Use.

REFERENCES for remodels into host bone within 6-12 months
Hofmann et al. ‘Autologous Iliac Bone Graft Compared with Biphasic Hydroxyapatite and Calcium Sulfate Cement for the
Treatment of Bone Defects in Tibial Plateau Fractures – A Prospective, Randomized, Open-Label, Multicenter Study.’J Bone Joint Surg Am. 2020;102:179-93.

Hettwer et al. ‘Establishment and effects of allograft and synthetic bone graft substitute treatment of a critical size metaphyseal bone defect model in the sheep femur’. APMIS 2019; 127:53–63.

Kaczmarczyk et al. ‘Complete twelve month bone remodeling with a bi-phasic injectable bone substitute in benign bone tumors: a prospective pilot study’. BMC Musculo. Dis. 2015;16:369.

REFERENCES for injectable and flowable
CERAMENT® G Instructions for Use.

Nilsson, M. ‘Injectable calcium sulphate and calcium phosphate bone substitutes’. Lund University. 2003. ISBN: 91-628-5603-0.

Hettwer et al. ‘Establishment and effects of allograft and synthetic bone graft substitute treatment of a critical size metaphyseal bone defect model in the sheep femur’. APMIS 2019; 127:53–63.

REFERENCES for gentamicin elution above MIC that is reliable and consistent
Stravinskas et al. ‘Pharmacokinetics of gentamicin eluted from a regenerating bone graft substitute – in vitro and clinical release studies’. Bone Joint Res. 2016;5:427-435.

Stravinskas et al. ‘Antibiotic containing bone substitute in major hip surgery: a long term gentamicin elution study’. J. Bone Joint Inf. 2018;3(2):68-72.

REFERENCES for high local concentration of gentamicin, without high serum gentamicin levels
Stravinskas et al. ‘Pharmacokinetics of gentamicin eluted from a regenerating bone graft substitute – in vitro and clinical release studies’. Bone Joint Res. 2016;5:427-435.

Colding-Rasmussen et al. ‘In-vivo and in-vitro evaluation of vancomycin and gentamicin elution from bone graft substitutes.’ European Bone and Joint Infection Society (EBJIS) 35th Annual Meeting, Oxford, September 2016.

Gentamicin 40mg/ml Solution for Injection or Infusion – Summary of Product Characteristics (SmPC) – (emc) (medicines.org.uk)