Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-03 @ 3:11 AM
Study NCT ID:
NCT00243295
Status:
COMPLETED
Last Update Posted:
2006-10-06
First Post:
2005-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Study Overview
Official Title:
A Pilot Study to Validate the Feasibility of Injecting and Monitoring Recombinant Human Bone Morphogenetic Protein-2/Calcium Phosphate Matrix (rhBMP-2/CPM) 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-2/CPM in OWO as a surgical model for pharmacodynamic studies, with assessment of the following parameters:
* Injecting the desired volume of rhBMP-2/CPM within the defect
* Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence of rhBMP-2/CPM.
* Injecting the desired volume of rhBMP-2/CPM within the defect
* Conducting longitudinal radiographic absorptiometry of the tibial defect in the presence of rhBMP-2/CPM.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: