Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo IIIA and IIIB Tibial Open Fractures
Brief Summary: This is a prospective, multi-national, multicenter, randomized, two arms, single blind, Standard of Care (SOC) controlled, with blinded central reading center study. This study will assess the safety and performance of BonyPid-1000™ in severe open tibial fractures (Gustilo IIIA and IIIB) when implanted as adjunct to SOC and compared to SOC alone.