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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhBMP-2/CPM | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the safety of administering rhBMP-2/CPM to subjects with distal radius fractures that require surgical fixation. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the test article injection procedure and localization of the test article relative to the distal radius fracture site. |
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Inclusion Criteria:
Other inclusion applies.
Exclusion Criteria:
Other exclusion applies.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Finland, MedInfoNord@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio | 70211 | Finland | ||||
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| ID | Term |
|---|---|
| D011885 | Radius Fractures |
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D005543 | Forearm Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| Oulu |
| 70211 |
| Finland |
| Turku | 20520 | Finland |
| Créteil | 94010 | France |
| Paris | 75012 | France |
| Paris | 75651 | France |
| Paris | 75970 | France |
| D014954 |
| Wrist Injuries |