rhBMP-2/CPM in Closed Diaphyseal Tibial Fractures
ID Number 06-1240Principal Investigator(s)
Edward C Yang
Department(s) or Division(s)
The primary objectives of this study are: To demonstrate that rhBMP-2/CPM reduces the time to fracture union compared to SOC alone, based on radiographic assessments by a central evaluation committee (CEC). To demonstrate acceleration of return to normal function based on the time to full weight bearing (FWB) without pain at the fracture site, as established by the investigator. The secondary objectives are: To demonstrate safety of rhBMP-2/CPM administration including key safety outcomes. To demonstrate earlier return to function with the Short Musculoskeletal Function Assessment (SMFA).
Recruiting Patients: Yes