The University of Mainz Initiates CERAMENT™| Tibia Fracture Study (CERTiFy) Controlled, prospective, randomized clinical trial comparing CERAMENT™| BONE VOID FILLER with autologous bone
LUND, Sweden, March 26, 2013 /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 the start of a CERAMENT™|Tibia Fracture Study (CERTiFy). CERTiFy is a controlled, prospective, randomized clinical trial comparing the use of CERAMENT™| BONE VOID FILLER with autologous bone taken from the patients iliac crest, the current gold standard for bone graft procedure for the management of tibia plateau fractures.
CERTiFy has been approved by the Ethical Committee in Rheinland-Palatinate (Mainz) and recruitment of patients into the study has begun. The study aims to include 140 patients from fourteen of the top orthopedic trauma centers in Germany. Professor P.M. Rommens, head of The Department of Traumatology, Musculoskeletal Surgery at The University Medical Centre Mainz is the Principal Clinical Investigator for the CERTiFy study.
"Cancellous bone grafting, the gold standard used in metaphyseal bone defects, entails an additional surgical intervention and a risk of specific complications such as pain, blood loss with the need of blood transfusion, and iatrogenic fractures, all of which are felt to impact the patient even more than the original fracture," said Prof. Rommens. "A number of alternatives are available including synthetic bone graft substitutes with clinical benefits and improvement of quality of life for the patient that until now have remained unproven scientifically. CERTiFy aims to demonstrate that CERAMENT™|BONE VOID FILLER can lead to real benefits for the patient and possibly for the national health systems with no second intervention."
Surgical Intervention is associated with risk of infection, blood loss, lengthy hospital stay, rehabilitation requirements and prolonged time to return to work. Using CERAMENT eliminates the need for a second surgical intervention and the expenses associated. The CERTiFy study is an important initiative that may help to quantify the benefits of CERAMENT™|BONE VOID FILLER.
Prof. Rommens went on to add, "The characteristics of CERAMENT™|BONE VOID FILLER are very attractive with qualities which we have not found in alternative bone substitutes, we therefore have chosen this product to conduct the prospective randomized multicenter study."
"CERAMENT has been used in more than 4000 clinical cases with convincing results, and continues to be the first choice for more and more surgeons," said Lloyd Diamond, CEO of BONESUPPORT. "We view the CERTiFy study as an integral part of our continuing commitment to surgeons and patients globally to develop and deliver innovative products with scientifically proven benefits and cost-savings to the healthcare system."
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 more than 4,000 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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