Dr. Daniels commented on the results of the trial, “Augment Injectable Bone Graft demonstrated at least equivalent, and potentially faster, healing outcomes compared to autograft in this study. I have been impressed with the improved handling and delivery characteristics of Augment Injectable compared to other available bone graft alternatives currently being used. Should Augment Injectable receive Health Canada approval, I believe it will be widely used by surgeons who are interested in sparing patients the additional pain and potential risks associated with traditional autograft bone harvest. Further, given the injectable nature of the material and improved handling characteristics, Augment Injectable may expand the indications for bone grafting.”
The Company expects to file the Device License Application (DLA) for approval of Augment Injectable in Canada this summer.
This study was a multi-center, randomized (5:1; AIBG to autograft), controlled trial to examine the safety and efficacy of AIBG as compared to autograft for ankle and hindfoot fusions. As pointed out during Dr. Daniels’ presentation, in addition to the prospectively randomized autograft patients, the study utilized the existing autograft database from a previous pivotal clinical trial utilizing a highly similar study design, and including the same surgeons, among others, to increase the statistical robustness of the data as per the study protocol approved by Health Canada.The primary endpoint was percentage of subjects fused as assessed by CT scan at 24 weeks (defined as ≥50% osseous bridging) as determined by an independent blinded radiologist. CT scans were performed at nine, 16, 24 and 36 weeks. Secondary endpoints included clinical evaluations, such as clinical success rate (no revision surgery required and improved pain on weight bearing), VAS pain assessment, functional outcome assessment scores (AOFAS Ankle-Hindfoot Scale, Foot Function Index, and SF-12) and radiographs. The historical autograft database was derived from the Augment Bone Graft pivotal trial.