Bonesupport touts high infection eradication rate in prospective trial

Bonesupport today released data from the prospective trial of its Cerament G injectable antibiotic-eluting bone substitute, touting a 96% infection eradication rate in patients treated with the substitute.

Data from the study was published in The Bone and Joint Journal, the company said.

Cerament G is an osteoconductive, ceramic substance designed to promote bone healing while preventing bone infection, or osteomyelitis. The resorbable bone graft substitute is designed to remodel into healthy bone within 6-12 months, while preventing colonization of microorganisms by eluting the antibiotic gentamicin.

“The results that we have achieved with the single stage surgical procedure using Cerament G for the dead space management of patients with chronic osteomyelitis are a significant improvement on past experience. These results reflect Cerament G’s unique local antibiotic delivery profile and its attractive bone remodelling capabilities. We are increasingly using Cerament G in the treatment of patients with chronic osteomyelitis and infected fractures. It allows a more patient-friendly treatment, preventing repeated operations and recurrent infections. We expect it to become the mainstay of our dead space management, given the major clinical and health economic benefits that it supports,” lead author Martin McNally of the U.K.’s Oxford University Hospitals said in a press release.

Data from 12-34 month follow ups from the 1st 100 patients in the study indicated a 96% prevention of infection recurrence rate, a 3% fracture fracture rate and total wound leakage rate of 6%, which the Swedish company said is “significantly lower than published results with alternative bone graft substitutes that deliver antibiotics locally.”

The prospective study is investigating the use of Cerament G for dead space management in single stage surgical procedures for chronic osteomyelitis, the company said.

Bonesupport said Cerament G, which won CE Mark approval in the European Union back in February 2013, is on the market in 19 countries.

Last month, Bonesupport said it won an investigational device exemption for the Fortify clinical trial of its next-generation Cerament G.

The 230-patient Fortify study is designed to evaluate the safety and efficacy of Cerament G in surgical repair of open diaphyseal tibial fractures, Lund, Sweden-based Bonesupport said, noting that it hopes to enroll 50% of the trial’s subjects in the U.S. Enrollment is expected to begin by the end of the year, the company said.

Other study endpoints include the absence of deep infection at the fracture site and absence of surgical or nonsurgical secondary procedures to promote fracture union, Bonesupport said.

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