Augment Bone Graft: Phase III data

Top-line data from a U.S. and Canadian Phase III trial showed that Augment Bone Graft missed the primary endpoint of non-inferiority to autograft as determined by proportion of patients achieving?>=50% bone bridging on CT scan at 24 weeks in the intent-to-treat population (n=434; 57.9% vs. 60.4%, p=0.065). However, Augment was non-inferior to autograft on a per joint basis (65.2% vs. 64.6%, p=0.004, n=631 joints) and the secondary endpoints of non-inferiority to autograft in union rates (79.6% vs. 79.2%, p=0.004) and in delayed/nonunion rates (8.1% vs. 10.7%, p=0.015). Autograft is the historical standard of care. ...