A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures

Stopped early · Phase 2/Phase 3

Conditions studied: Fractures

In brief

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 fracture union and return to normal function in subjects who have a closed diaphyseal tibial fracture when compared to standard of care alone.

Key facts

Study ID

NCT00387686

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

367

Starts

2006-11-01

Expected to finish

2010-03-01

Last updated by the study team

2013-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Aurora, Colorado, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — New Haven, Connecticut, United States
• Pfizer Investigational Site — Pinellas Park, Florida, United States
• Pfizer Investigational Site — Fort Wayne, Indiana, United States
• Pfizer Investigational Site — Indianapolis, Indiana, United States
• Pfizer Investigational Site — Baltimore, Maryland, United States
• Pfizer Investigational Site — Kalamazoo, Michigan, United States
• Pfizer Investigational Site — Portage, Michigan, United States
• Pfizer Investigational Site — Lebanon, New Hampshire, 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 — Charlotte, North Carolina, United States
• Pfizer Investigational Site — Memphis, Tennessee, United States
• Pfizer Investigational Site — Buenos Aires, Argentina
• Pfizer Investigational Site — Liverpool, New South Wales, Australia
• Pfizer Investigational Site — New Lambton, New South Wales, Australia
• Pfizer Investigational Site — Herston, Queensland, Australia
• Pfizer Investigational Site — Adelaide, South Australia, Australia
• Pfizer Investigational Site — Cerequeira Cesar, São Paulo, Brazil
• Pfizer Investigational Site — Vila Clemetino, São Paulo, Brazil
• Pfizer Investigational Site — Ajax, Ontario, Canada
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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