AUGMENT® Bone Graft
As reported by Dr. DiGiovanni and co-authors (JBJS, 2013), AUGMENT® Bone Graft demonstrated similar improvements to patients treated with autograft as seen in clinical, functional, and safety outcomes without the need for a second surgical procedure to harvest autograft. The trial demonstrated that out of 16 secondary endpoint measures at the 52-week time point, 15 were statistically significant for non-inferiority.
Importantly, safety outcomes favored the AUGMENT® Bone Graft treatment group, which had fewer complications and infections compared to patients treated with autograft. AUGMENT® Bone Graft was approved by FDA (PMA P100006) based on reasonable assurance of safety, effectiveness, and risk-to-benefit. AUGMENT® Bone Graft is also approved and commercially available in Australia, New Zealand, Canada and Mexico; and is now available in the U.S.
North American Pivotal Trial Data Summary