Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures

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.

Timeline

Start

2005-09

Primary completion

—

Completion

2007-01

Drugs

Indications

No indication recorded.