Bonesupport has announced the commencement of a study comparing Cerament bone void filler with autologous bone taken from the patient’s iliac crest.
The University of Mainz, Germany, has begun patient recruitment for the controlled, prospective, randomised study, Certify, which is approved by the Ethical Committee in Rheinland-Palatinate (Mainz).
University Medical Centre Mainz musculoskeletal surgery department of traumatology head and Certify study principal clinical investigator Professor P M Rommens said the leading treatment for metaphyseal bone defects, cancellous bone grafting, involves extra surgical intervention in addition to specific complications that show a negative impact on the patient.
"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," Rommens said.
"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."
A total of 140 patients from fourteen of the top orthopaedic trauma centres in Germany are expected to be enrolled in the study.
Risk of infection, blood loss, lengthy hospital stay, rehabilitation requirements and prolonged time to get back to routine are all coupled with surgical intervention.
Cerament is an injectable, synthetic bone substitute designed to avoid the need for a second surgical intervention.
The benefits of Cerament bone void filler are expected to be quantified in the study.
Bonesupport CEO Lloyd Diamond said; "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."