Sweden-based Bonesupport has announced that the Centre Hospitalier Universitaire Vaudois (CHUV) in Switzerland has initiated the Cerament |G Bone Healing study, designed to investigate absorption and bone in-growth of Cerament|G in one-stage surgical revisions of infections.
The Cerament|G Bone Healing study will follow patients for one-year post surgery. CT verified Cerament|G absorption and new bone in-growth are primary endpoints of the study.
Secondary and safety endpoints of the study are bone healing, post-operative infections and serum levels of gentamicin.
CHUV septic unit head and principal clinical investigator for the Cerament|G Bone Healing study Dr Olivier Borens said: "We believe the use of Cerament|G will be of advantage for the patient when bone healing can be achieved with a one-stage procedure instead of a two-stage procedure, thus decreasing potential surgery-related complications."
Bonesupport chief medical officer Dr Mogens Gisselbaeck said: "We expect the results of this study will further qualify the positive outcomes reported from the Oxford Cerament|G study, and that mounting Cerament|G data may impact the surgical strategy related to the management of bone infections."
Cerament |G is an injectable antibiotic eluting ceramic bone graft substitute indicated to promote and protect bone healing in the management of osteomyelitis (bone infections).
Cerament |G obtained received CE Mark approval and is currently available in select markets. Currently, it is not available in the US.