At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 277 enrolled
Drug / intervention
InductOsdrug
Likely dose
InductOs (rhBMP-2/ACS) 1.5 mg/ml implanted once at the time of definitive fracture coverageAI-extracted
Key inclusion· 4
- ✓Acute open tibial shaft fractures Gustilo Type I, II, IIIA, or IIIB requiring reamed locked intramedullary nail fixation and at low amputation risk
- ✓Age ≥18 years and skeletally mature
- ✓Initial fracture stabilization and wound debridement within 1 day after injury
- ✓Definitive fracture coverage within 14 days after injury
Key exclusion· 3
- ✕Planned treatment should not include further procedures to promote fracture healing (before 16 weeks)
- ✕Fracture distraction >2 mm following definitive fracture fixation
- ✕Purulent drainage or evidence of active osteomyelitis at fracture site
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Controlled, Stratified Study of InductOs in Subjects With Open Diaphyseal Tibia Fractures Treated With Reamed Locked Intramedullary Nail Fixation
Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Sep 12, 2005·Updated Sep 7, 2009
In Brief
A Phase 4 clinical trial evaluating InductOs for Tibial Fractures. Completed, enrolled 277 participants across 27 sites in 12 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTibial Fractures
CountriesBelgium, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Romania, South Africa, Spain, United Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2003
First PostedSep 2005
Primary CompletionJul 2008
Study CompletionAug 2008
TodayJul 2026
First PostedSep 12, 2005
Enrollment StartSep 1, 2003
Primary CompletionJul 1, 2008
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 20.8 years ago
Interventions
InductOsdrug
InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage