Dr. Timothy Daniels, associate professor of orthopedic surgery at the University of Toronto and St. Michaels Hospital and lead investigator, presented today the results of a Canadian registration study comparing Augment™ Injectable Bone Graft (AIBG) to autograft in foot and ankle fusion surgery. Augment Injectable is an injectable bone graft developed by BioMimetic Therapeutics, Inc. (NASDAQ: BMTI). The presentation took place on Thursday, June 21, 2012, at the American Orthopaedic Foot and Ankle Society (AOFAS) annual meeting. As presented by Dr. Daniels, the trial met its primary endpoint of non-inferiority of AIBG to autograft as assessed by CT scan at six months.
Dr. Daniels reported that assessment of the primary endpoint revealed that 53/63 (84.1%) of the AIBG-treated patients and 100/154 (64.9%) of the autograft-treated patients were fused as determined by six month CT scans (p<0.001). Patients were followed clinically for 52 weeks, at which time 57/63 (90.5%) of the Augment Injectable patients and 120/154 (77.9%) of autograft patients achieved clinical success (p<0.001).
Additionally, patients treated with AIBG were shown to have equivalent functional outcomes with less pain than patients treated with autograft (as seen in the table below).
52 Week Results
|Mean± sd||Mean± sd||p-value|
|Foot Function Index||15.0 ± 17.5||17.4 ± 20.4||< 0.001|
|AOFAS Ankle-Hindfoot Scale||80.0 ± 13.9||78.5 ± 17.0||< 0.001|
|Fusion Site Pain||12.2 ± 19.4||13.0 ± 23.5||< 0.001|
|Weight Bearing Pain||13.0 ± 20.0||15.6 ± 25.4||< 0.001|
|Graft Site Pain||0||6.2 ± 16.6||< 0.001|
|SF-12 (PCS)||44.6 ± 8.5||45.0 ± 9.7||< 0.001|
*Lower FFI and pain scores indicate better outcome. Higher AOFAS and SF-12 scores indicate better outcome.
No safety concerns were identified, and all Augment Injectable-treated patients were spared the additional risk and morbidity of bone graft harvest.