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To assess the feasibility of using rhBMP-2/CPM in OWO as a surgical model for pharmacodynamic studies, with assessment of the following parameters:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhBMP-2/CPM | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of injecting rhBMP-2/CPM using high tibial osteotomy as a surgical model for pharmacodynamic studies | ||
| Feasibility measures include | ||
| Injection of desired volume of rhBMP-2/CPM within the osteotomy defect | ||
| Ability to perform longitudinal radiographic absorptiometry of the defect in the presence of rhBMP-2/CPM. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of administering different volumes of rhBMP-2/CPM in high tibial osteotomy defects. Safety assessed by evaluation of adverse events reported during the duration of the trial. |
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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 |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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