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Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures

NCT02820363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2021-08-10

No results posted yet for this study

Summary

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.

Conditions

  • Tibial Fracture

Interventions

DEVICE

CERAMENT|G

Surgical repair of tibia fracture, CERAMENT™\|G applied to bony voids.

PROCEDURE

SOC treatment

surgical repair of tibial fracture

Sponsors & Collaborators

  • BONESUPPORT AB

    lead INDUSTRY

Principal Investigators

  • Douglas R. Dirschl, MD · The University of Chicago Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-02-14
Primary Completion
2021-07-31
Completion
2021-07-31
FDA Device
Yes

Countries

  • United States
  • Germany
  • Poland
  • United Kingdom

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 NCT02820363 on ClinicalTrials.gov