Augment Injectable Bone Graft: Pivotal trial data

A pivotal Canadian trial in 217 patients showed that Augment Injectable Bone Graft met the primary endpoint of non-inferiority to autograft in the proportion of patients who achieved >=50% osseous bone bridging as evaluated by CT scan at 6 months (84.1% vs. 64.9%, p<0.001 for non-inferiority). Augment Injectable Bone Graft was also non-inferior to autograft in mean time to fusion (14.3 vs. 19.7 weeks, p<0.001 for non-inferiority). Additionally, 90.5% of Augment Injectable patients achieved clinical success at week 52 vs. 77.9% for autograft (p<0.001 for non-inferiority). Augment Injectable was also non-inferior to autograft in Foot Function Index scores, Ankle-Hindfoot Scale scores, fusion site pain, weight bearing pain and graft site pain vs. autograft (p<0.001 for all for non-inferiority). Data were presented at the American Orthopedic Foot and Ankle Society meeting in San Diego. ...