Status:
COMPLETED
Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Fractures
Eligibility:
All Genders
55+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as an adjuvant to internal fixation in subjects with fractures of the proximal femur.
Eligibility Criteria
Inclusion
- Age 55 or older.
- Acute fracture of the proximal femur: displaced femoral neck fracture or unstable intertrochanteric femur fracture.
- Anatomic reduction (open or closed) and internal fixation within 48 hours following injury using any one of the following fixation constructs: 1) multiple parallel interfragmentary screws; 2) sliding hip screw and side plate fixation; or 3) cephalomedullary nail.
Exclusion
- Concurrent fractures of the ipsilateral or contralateral lower extremity that would impede performance on functional assessments.
- Previous arthroplasty of contralateral (unaffected) hip.
- Planned procedure(s) to stimulate fracture healing after internal fixation of the fractured hip.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00384358
Start Date
December 1 2006
End Date
June 1 2010
Last Update
February 28 2013
Active Locations (30)
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1
Pfizer Investigational Site
Aurora, Colorado, United States, 80012
2
Pfizer Investigational Site
New Haven, Connecticut, United States, 06520
3
Pfizer Investigational Site
Clearwater, Florida, United States, 33756
4
Pfizer Investigational Site
Pinellas Park, Florida, United States, 33703