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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Unnamed facility
Kuopio, Finland
Unnamed facility
Oulu, Finland
Unnamed facility
Turku, Finland
Unnamed facility
Créteil, France
Unnamed facility
Paris, France
Determine the safety of administering rhBMP-2/CPM to subjects with distal radius fractures that require surgical fixation.
Feasibility of the test article injection procedure and localization of the test article relative to the distal radius fracture site.
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Unnamed facility
Paris, France
Unnamed facility
Paris, France