CERTiFY is a prospective, randomized, controlled clinical study designed to compare the differences in pain, quality of life, and cost of care in the treatment of tibia plateau fracture-associated bone defectsusing either CERAMENT|BONE VOID FILLER (CERAMENT BVF) or autologous bone grafting (autograft). Autograft is the current gold standard for bone graft procedure for the management of tibia plateau fractures.
The primary outcome of the study is based on data from the SF-12 Physical Component Summary, which assesses the patient’s physical functioning, at week 26. The co-primary endpoint is the pain level 26 weeks after surgery measured by a visual analog scale. The SF-12 Mental Component Summary after 26 weeks and the costs of care will serve as key secondary endpoints.
Initial top-line data from the study is expected towards the end of 2018. A publication providing more complete data from the CERTiFy study is expected in Q1 2019.
The CERTiFy study recruited patients from 20 orthopedic trauma centers in Germany.
“We are pleased to have achieved this important milestone in the CERTiFy study that demonstrates BONESUPPORT’s ability to run significant complex multi-centre studies and generate Level I data that has the potential to change the practice of medicine. We are confident that positive data from CERTiFy would lead to much greater uptake of all CERAMENT products across multiple trauma indications due to their ease of use and lower procedure costs,” said BONESUPPORT CEO Richard Davies.