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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
108
one time injection of 3-5 mL test article at time of internal fracture fixation
one time injection of 3-5 mL test article at time of internal fracture fixation
surgical internal fixation of fracture defines the standard of care group
The safety outcome is the incidence of secondary fracture displacement among subjects treated with rhBMP-2/CPM compared to those receiving standard surgical treatment (internal fixation) alone.
Time frame: upon completion 6 months of follow-up
To establish a satisfactory method of administering rhBMP-2/CPM to implement in a phase 3 efficacy trial in this clinical indication.
Time frame: 6 months follow-up
To estimate the success and failure rates associated with key fracture outcomes.
Time frame: 6 months follow-up
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Pfizer Investigational Site
Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Clearwater, Florida, United States
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Pinellas Park, Florida, United States
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Decatur, Georgia, United States
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New Brunswick, New Jersey, United States
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Brooklyn, New York, United States
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Elmhurst, New York, United States
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Liverpool, New South Wales, Australia
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Herston, Queensland, Australia
...and 20 more locations