Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures

Completed · Phase 2

Conditions studied: Fractures

In brief

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.

Key facts

Study ID

NCT00384358

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

108

Starts

2006-12-01

Expected to finish

2010-06-01

Last updated by the study team

2013-02-28

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Aurora, Colorado, United States
• Pfizer Investigational Site — New Haven, Connecticut, United States
• Pfizer Investigational Site — Clearwater, Florida, United States
• Pfizer Investigational Site — Pinellas Park, Florida, United States
• Pfizer Investigational Site — Decatur, Georgia, United States
• Pfizer Investigational Site — New Brunswick, New Jersey, United States
• Pfizer Investigational Site — Brooklyn, New York, United States
• Pfizer Investigational Site — Elmhurst, New York, United States
• Pfizer Investigational Site — Liverpool, New South Wales, Australia
• Pfizer Investigational Site — Herston, Queensland, Australia
• Pfizer Investigational Site — Adelaide, South Australia, Australia
• Pfizer Investigational Site — Melbourne, Victoria, Australia
• Pfizer Investigational Site — Parkville, Victoria, Australia
• Pfizer Investigational Site — Ajax, Ontario, Canada
• Pfizer Investigational Site — Chatham, Ontario, Canada
• Pfizer Investigational Site — Scarborough Village, Ontario, Canada
• Pfizer Investigational Site — Montreal, Quebec, Canada
• Pfizer Investigational Site — Oulu, Finland
• Pfizer Investigational Site — Turku, Finland
• Pfizer Investigational Site — Créteil, France
• Pfizer Investigational Site — Marseille, France
• Pfizer Investigational Site — Berlin, Germany
• Pfizer Investigational Site — Münster, Germany
• Pfizer Investigational Site — Budapest, Hungary
• Pfizer Investigational Site — Debrecen, Hungary

Full record on ClinicalTrials.gov

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