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Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures

NCT02491047 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2020-05-19

No results posted yet for this study

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.

Conditions

  • Tibial Fractures
  • Open Fractures

Interventions

DEVICE

BonyPid-1000

BonyPid-1000 implantation concomitantly to standard of care (SOC) treatment

OTHER

Standard of Care (SOC) treatment

Standard of Care (SOC) treatment only

Sponsors & Collaborators

  • PolyPid Ltd.

    lead INDUSTRY

Principal Investigators

  • Shany Blum, Dr. · PolyPid Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Israel
  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02491047 on ClinicalTrials.gov