FORTIFY Clinical Trial: A Prospective, Randomized Multicenter Controlled Trial of CERAMENT G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures (NCT02820363)
The purpose of this study is to demonstrate the safety and effectiveness of CERAMENT G used in conjunction with standard-of-care treatment compared to standard-of-care treatment alone in the care of subjects with open fractures of the tibial diaphysis.*
This study is being conducted at hospitals in the United States and Europe, and enrollment was completed in 2020.
Principal Investigator: Douglas R. Dirschl, MD, The University of Chicago Medicine
For More Information on participating centers, trial endpoints and inclusion criteria, visit https://clinicaltrials.gov/ct2/show/NCT02820363
*an open tibia (shinbone) fracture is one where the skin is broken and the bone is exposed to the outside
Notice of availability: CERAMENT G is not available in the United States, for investigational use only.