CERTiFy (CERAMENT™|Tibia Fracture) Study Protocol Published In TRIALS
LUND, Sweden, March 12, 2014 /PRNewswire/ -- BONESUPPORT, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, together with the University of Mainz in Germany, announced that the protocol for the CERAMENT™|Tibia Fracture Study (CERTiFy) was recently published in TRIALS, an open access, peer reviewed online journal. CERTiFy is a controlled, prospective, randomized clinical trial comparing the use of CERAMENT™|BONE VOID FILLER with the current gold standard for bone graft procedures in the management of tibia plateau fractures. CERTiFy will include 136 patients from more than a dozen top orthopedic trauma centers in Germany.
"The acceptance of the CERTiFy protocol for publication in TRIALS is an honor and a validation of the high quality of this prospective, multicenter, controlled, randomized trial," said Professor P.M. Rommens, head of The Department of Traumatology, Musculoskeletal Surgery, The University Medical Centre Mainz, and Principal Clinical Investigator for the study. "The CERTiFy study is an important initiative to quantify the benefits of CERAMENT™ and we look forward to sharing key findings."
Surgical intervention involving bone grafting of the iliac crest is the current gold standard and is associated with risk of infection, blood loss, lengthy hospital stay and prolonged rehabilitation and recovery. Using CERAMENT™ eliminates the need for a second surgical intervention as well as the associated risk and expense. Dr. Mogens Gisselbaek, Chief Medical Officer of BONESUPPORT noted, "The outcome of the CERTiFy trial could eliminate the need for this extra surgical procedure and provide evidence-based data to support new treatment methodologies that improve patient outcomes."
"CERAMENT™ has been used in nearly 9,000 patients with convincing results and is quickly becoming the first choice bone substitute for more and more surgeons," said Lloyd Diamond, CEO of BONESUPPORT. "The CERTiFy study is an integral part of our commitment to evidence based research aimed at improving treatment protocols and health outcomes."
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 U.S. 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 US and Germany. To learn more about BONESUPPORT please visit www.bonesupport.com.
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