Status:
COMPLETED
Study Evaluating InductOs in Diaphyseal Tibia Fractures
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Tibial Fractures
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 intram...
Eligibility Criteria
Inclusion
- Subjects with acute open tibial shaft fractures (Gustilo Type I, II, IIIA, or IIIB) who require surgical management with reamed, statically locked intramedullary nail fixation and who are at low risk for amputation.
- Subjects should be at least 18 years of age, be skeletally mature, and be able to provide written informed consent.
- Initial fracture stabilization and wound debridement should occur within 1 day after injury and DFC should occur within 14 days after injury.
Exclusion
- Planned treatment for the fracture should not include further procedures to promote fracture healing. After 16 weeks have elapsed since DFC, unanticipated procedures to promote fracture healing are permitted as clinically indicated.
- Presence of fracture distraction \> 2 mm following definitive fracture fixation.
- Presence of purulent drainage from the fracture site or evidence of active osteomyelitis.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT00161616
Start Date
September 1 2003
End Date
August 1 2008
Last Update
September 7 2009
Active Locations (27)
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1
Ghent, Belgium, 9000
2
Turku, Finland, 20520
3
Créteil, France, 94010
4
Toulouse, France, 31400