Trials / Completed
CompletedNCT00161616
Study Evaluating InductOs in Diaphyseal Tibia Fractures
A Prospective, Randomized, Controlled, Stratified Study of InductOs in Subjects With Open Diaphyseal Tibia Fractures Treated With Reamed Locked Intramedullary Nail Fixation
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 277 (actual)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | InductOs | InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage |
Timeline
- Start date
- 2003-09-01
- Primary completion
- 2008-07-01
- Completion
- 2008-08-01
- First posted
- 2005-09-12
- Last updated
- 2009-09-07
- Results posted
- 2009-09-07
Locations
27 sites across 12 countries: Belgium, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Romania, South Africa, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00161616. Inclusion in this directory is not an endorsement.