LUND, Sweden, June 19, 2014 /PRNewswire/ -- BONESUPPORT, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, announced the initiation of a CERAMENT™|G Bone Healing study by the CHUV (Centre Hospitalier Universitaire Vaudois), in Lausanne, Switzerland. The CERAMENT™|G Bone Healing study is a prospective, controlled, cohort study investigating the absorption and bone in-growth of CERAMENT™|G in one-stage surgical revisions of bone infections. Dr. Olivier Borens, head of the septic unit at the CHUV, is principal clinical investigator for the study, which will follow patients for 12 months post surgery.
"The surgical management of bone infections is often challenging and requires a two-stage surgical intervention," said Dr. Olivier Borens, primary investigator, CHUV, Lausanne, Switzerland. "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 Dr. Mogens Gisselbaeck, 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 verified CERAMENT™|G absorption and new bone in-growth. Secondary and safety endpoints are bone healing, post-operative infections and serum levels of gentamicin.
CERAMENT™|G is the first 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.
BONESUPPORT is an emerging leader of injectable bone graft substitutes for orthopedic trauma focusing on bone infection, instrument augmentation and spinal applications. CERAMENT™ is an injectable, synthetic bone substitute that mimics the properties of cancellous bone, allows for controlled resorption to support future bone ingrowth and is injectable under local anesthesia for minimally invasive surgery. CERAMENT's unique biologic properties deliver a consistent, pre-packed and ready-to-use formulation to facilitate optimal delivery. CERAMENT™|G is the first CE-marked injectable antibiotic eluting ceramic bone graft substitute. CERAMENT™|G is indicated to promote and protect bone healing in the management of osteomyelitis, (bone infections) in CE marked countries. CERAMENT™|G is not available in the United States.
CERAMENT™ is a fully developed product platform that is commercially available in the United States and Europe and is revolutionizing the treatment of fragility and other fractures caused by disease and trauma. Scientific research of CERAMENT spans more than eleven years. Over forty-five pre-clinical, clinical and animal studies have been conducted and close to 9,000 patients have been treated with CERAMENT. The company was founded in 1999 and is based in Lund, Sweden with subsidiary locations in the United States and Germany. To learn more about BONESUPPORT please visit www.bonesupport.com.
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