- Subjects with acute open tibial shaft fractures (Gustilo Type I, II, IIIA, or IIIB)
who require surgical management with reamed, statically locked intramedullary nail
fixation and who are at low risk for amputation.
- Subjects should be at least 18 years of age, be skeletally mature, and be able to
provide written informed consent.
- Initial fracture stabilization and wound debridement should occur within 1 day after
injury and DFC should occur within 14 days after injury.
- Planned treatment for the fracture should not include further procedures to promote
fracture healing. After 16 weeks have elapsed since DFC, unanticipated procedures to
promote fracture healing are permitted as clinically indicated.
- Presence of fracture distraction > 2 mm following definitive fracture fixation.
- Presence of purulent drainage from the fracture site or evidence of active
osteomyelitis.