Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures
Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
Participant gender:
Summary
To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal
radius fractures. The key safety variables comprising this assessment are: 1) incidence of
delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence
of local neurovascular events (those involving the region under study [RUS]); and 4) rate of
fracture displacement. The primary objective will be met if these outcomes in the active and
placebo treatment groups are at least comparable to those of the SOC control group.