- 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.
- Concurrent fractures of the ipsilateral or contralateral lower extremity other than
the ipsilateral fibula, that would impede performance on the functional assessment of
- Planned procedure(s) to stimulate fracture healing after intramedullary nailing.
- Neurovascular impairment of the fractured limb, deep vein thrombosis, or (impending)