Status:
TERMINATED
A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Fractures
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered at the fracture site via percutaneous injection, in combination with standard of care, accelerates fr...
Eligibility Criteria
Inclusion
- Skeletally mature, male and female subjects who are at least 18 years old.
- Closed diaphyseal tibial fracture.
- Closed reduction and definitive internal fixation by means of a reamed, locked intramedullary nail within 72 hours after injury.
Exclusion
- Concurrent fractures of the ipsilateral or contralateral lower extremity other than the ipsilateral fibula, that would impede performance on the functional assessment of weight bearing.
- Planned procedure(s) to stimulate fracture healing after intramedullary nailing.
- Neurovascular impairment of the fractured limb, deep vein thrombosis, or (impending) compartment syndrome.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT00387686
Start Date
November 1 2006
End Date
March 1 2010
Last Update
February 28 2013
Active Locations (68)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294-3708
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
3
Pfizer Investigational Site
Aurora, Colorado, United States, 80012
4
Pfizer Investigational Site
Denver, Colorado, United States, 80204