Clinical Trial: Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo IIIA and IIIB Tibial Open Fractures
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.
Detailed Summary:
Sponsor: PolyPid Ltd.
Current Primary Outcome:
- Safety: Deep Infection in the target fracture site [ Time Frame: During the 4 weeks post index procedure ]
- Performance: Radiographic-assessed bone healing [ Time Frame: During the 24-week follow-up period ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: PolyPid Ltd.
Dates:
Date Received: July 2, 2015
Date Started: October 2015
Date Completion: January 2018
Last Updated: December 6, 2016
Last Verified: November 2016
