Study Evaluating InductOs in Diaphyseal Tibia Fractures

Summary

Demonstrate a larger proportion of subjects with healed fractures among subjects treated with InductOs and reamed, locked intramedullary nailing compared to subjects treated with reamed, locked intramedullary nailing alone.

Conditions

• Tibial Fractures

Interventions

DRUG

InductOs

InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

  lead INDUSTRY

Principal Investigators

• Medical Monitor · Wyeth is now a wholly owned subsidiary of Pfizer

• Trial Manager · For Germany, [email protected]

• Trial Manager · For Italy, [email protected]

• Trial Manager · For South Africa, [email protected]

• Trial Manager · For Norway, Finland, [email protected]

• Trial Manager · For Spain, [email protected]

• Trial Manager · For UK/Great Britian, [email protected]

• Trial Manager · For Belgium, [email protected]

• Trial Manager · For France, [email protected]

• Trial Manager · For Romania, [email protected]

• Trial Manager · For Netherlands, [email protected]

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-09-30

Primary Completion

2008-07-31

Completion

2008-08-31

Countries

• Belgium
• Finland
• France
• Germany
• Italy
• Netherlands
• Norway
• Poland
• Romania
• South Africa
• Spain
• United Kingdom

Study Locations