Decision was taken by Wyeth Sr. Management to early terminate the 3100N7-210 study (terminate enrollment but complete follow-up).

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.

Inclusion Criteria:

• 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 Criteria:

• 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.