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
, 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
, 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.