Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies
|ClinicalTrials.gov Identifier: NCT00243295|
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : October 6, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Drug: rhBMP-2/CPM||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2003|
|Estimated Study Completion Date :||March 2005|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00243295
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|