Study Evaluating rhMBP-2/CPM in Open Wedge Osteotomies

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

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.

Inclusion Criteria:

• Male or female subjects 45 to 70 years of age
• Within 96 hours prior to dosing, the subject underwent a successful open wedge tibial osteotomy to correct medial compartment OA of the knee.
• Female subjects of childbearing potential must have a negative pregnancy test (hospital acceptable test), upon hospitalization for OWO and agree to use medically approved contraception for the duration of the study.

Other inclusion applies.

Exclusion Criteria:

• Subjects with pre-existing conditions of the knee or tibia that would confound an interpretation of results.
• Subjects for whom surgery in the opposite knee is planned during the 6 months of follow-up.
• Subjects with a history of malignancy or radiotherapy or chemotherapy for malignancy within the past 5 years, except subjects with a history of basal skin carcinoma.

Other exclusion applies.