Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243295
Status:
COMPLETED
Last Update Posted:
2006-10-06
First Post:
2005-10-19
Brief Title:
Study Evaluating rhMBP-2CPM in Open Wedge Osteotomies
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Pilot Study to Validate the Feasibility of Injecting and Monitoring Recombinant Human Bone Morphogenetic Protein-2Calcium Phosphate Matrix rhBMP-2CPM in Subjects With Open Wedge Osteotomies
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the feasibility of using rhBMP-2CPM in OWO as a surgical model for pharmacodynamic studies with assessment of the following parameters
Injecting the desired volume of rhBMP-2CPM within the defect
Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence of rhBMP-2CPM
Injecting the desired volume of rhBMP-2CPM within the defect
Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence of rhBMP-2CPM
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None