TREATMENT

RHBMP-2 ADJUVANT TREATMENT IN FEMORAL HEAD OSTEONECROSIS (ON). PRESENTATION OF A NEW STUDY DESIGN AND OBJECTIVES.

B. MAZIERES, Ph. CHIRON, P. HERNIGOU, B. STULBERG and M. MONT

We study the effectiveness and safety of the osteoinductive factor rhBMP-2 implanted on an absorbable collagen sponge (ACS) as adjuvant treatment to core decompression. The objectives are to restore normal bone and prevent disease progression in stage I and II femoral head ON. This multicenter single-blinded, stratified, randomized, study, evaluates two concentrations of rhBMP-2 in patients requiring core decompression. Patients are followed for 3 years. Effectiveness will be determined by the percent change from baseline of necrotic bone volume, changes in ON staging (x-ray, MRI and QCT), functional assessment (Harris Score and Womac). Safety will be assessed by monitoring adverse events and antibody formation. Forty-five patients were enrolled and followed for an average of 52 weeks (min 26, max 78). Preliminary results indicate that rhBMP-2/ACS is well tolerated.