ARTICLE | Clinical News

Augment Bone Graft: Final Phase III data

July 26, 2010 7:00 AM UTC

Final data from the modified intent-to-treat (mITT) population (n=397) of a U.S. and Canadian Phase III trial showed that Augment Bone Graft was non-inferior to autograft on 15 of 16 radiographic, clinical, functional and pain-related secondary endpoints at week 52. The endpoints included rates of fusion, clinical healing, nonunion rates, clinical success, therapeutic failure, SF-12 Health Survey scores, mean foot fusion index, Ankle-Hindfoot Scale scores, VAS pain scores and graft site pain. The mITT population excluded 20 patients who were randomized but never treated, and 17 patients who developed major prospectively identified protocol deviations. Data were presented at the American Orthopedic Foot and Ankle Society meeting in National Harbor, Md. ...