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rhBMP-2 Versus Autograft in Critical Size Tibial Defects

NCT00853489 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2018-10-25

Study results available
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Summary

The purpose of our study is to evaluate the use of recombinant human bone morphogenetic protein 2 (RhBMP-2) as compared to standard ICBG in the treatment of severe open tibia fractures with a critical size bone defect (at least one centimeter in length compromising at least 50% of the circumference of the bone).

Conditions

  • Tibial Fractures

Interventions

DEVICE

recombinant bone morphogenetic protein 2

Patients will receive 1.50 mg/ml -12 mg of rhBMP-2 soaked on a absorbable collagen sponge (rhBMP-2/ACS) as an adjuvant to a freeze-dried cancellous allograft

PROCEDURE

Autogenous iliac crest bone graft

Patients will undergo autogenous iliac crest bone graft surgery per the surgeon's usual practice.

Sponsors & Collaborators

  • Major Extremity Trauma Research Consortium

    collaborator OTHER

  • St. Louis University

    lead OTHER

Principal Investigators

  • Thomas Revak, DO · St. Louis Medical Center

  • Paul Tornetta, MD · Boston Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2017-02-17
Completion
2017-02-17

Countries

  • United States

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 NCT00853489 on ClinicalTrials.gov