06.30.14
Bonesupport has begun the Cerament/G bone healing study by the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland. The prospective, controlled, cohort study will investigate absorption and bone in-growth of Cerament/G in one-stage surgical revisions of bone infections. Olivier Borens, M.D., head of the septic unit at the CHUV, is principal clinical investigator for the study, which will follow patients for 12 months post surgery.
Cerament/G is an injectable antibiotic eluting bone substitute indicated to promote and protect bone healing being jeopardized by infection, a condition where prolonged, long-term antibiotic therapy, multiple surgical interventions and the threat of amputation are the current standard of care. Rising prosthetic infections, diabetic ulcers, war injuries, sports injuries, and an increasing resistance to antibiotics contribute to the $1.7 billion bone infection market.
“The surgical management of bone infections is often challenging and requires a two-stage surgical intervention,” said Borens. “The aim of this study is to investigate the absorption and bone in-growth of Cerament/G in contaminated bone defects. 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.”
Current two-stage surgical revisions for bone infections include debridement to remove infected tissues and allow antibiotics access to the remaining pathogens. However, this often results in a large contaminated bony defect. Appropriate management of this dead space is essential to maintaining the bone’s integrity and controlling the infection.
“We are pleased to support this high quality investigator sponsored trial lead by Dr. Olivier Borens,” said Mogens Gisselbaeck, M.D., chief medical officer of Bonesupport. “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.”
Primary endpoints for the study are CT- (computed tomography) verified Cerament/G absorption and new bone in-growth. Secondary and safety endpoints are bone healing, post-operative infections and serum levels of gentamicin.
Bonesupport makes injectable bone graft substitutes for orthopedic trauma focusing on bone infection, instrument augmentation and spinal applications. The company is based in Lund, Switzerland.
Cerament/G is an injectable antibiotic eluting bone substitute indicated to promote and protect bone healing being jeopardized by infection, a condition where prolonged, long-term antibiotic therapy, multiple surgical interventions and the threat of amputation are the current standard of care. Rising prosthetic infections, diabetic ulcers, war injuries, sports injuries, and an increasing resistance to antibiotics contribute to the $1.7 billion bone infection market.
“The surgical management of bone infections is often challenging and requires a two-stage surgical intervention,” said Borens. “The aim of this study is to investigate the absorption and bone in-growth of Cerament/G in contaminated bone defects. 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.”
Current two-stage surgical revisions for bone infections include debridement to remove infected tissues and allow antibiotics access to the remaining pathogens. However, this often results in a large contaminated bony defect. Appropriate management of this dead space is essential to maintaining the bone’s integrity and controlling the infection.
“We are pleased to support this high quality investigator sponsored trial lead by Dr. Olivier Borens,” said Mogens Gisselbaeck, M.D., chief medical officer of Bonesupport. “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.”
Primary endpoints for the study are CT- (computed tomography) verified Cerament/G absorption and new bone in-growth. Secondary and safety endpoints are bone healing, post-operative infections and serum levels of gentamicin.
Bonesupport makes injectable bone graft substitutes for orthopedic trauma focusing on bone infection, instrument augmentation and spinal applications. The company is based in Lund, Switzerland.