Enrollment is complete in BONESUPPORT's FORTIFY study on CERAMENT® G orthobiologic, with 198 subjects enrolled.
BONESUPPORT recently requested a study protocol amendment to reduce the sample size by approximately 30 subjects due to anticipated enrollment challenges during the COVID-19 pandemic. A blinded sample size review by an independent clinical study statistician ensured that closing enrollment at 198 subjects has only a minimum impact on the statistical power of the study. FDA approved the request.
FORTIFY commenced in 2017 to evaluate the safety and efficacy of CERAMENT G with surgical repair of open diaphyseal tibial fractures versus standard of care. The results of the study are intended to support an FDA Premarket Approval filing for CERAMENT G. The company expects to submit a PMA application at the end of 2021.