This 2007 narrative review by McKay et al. (Medtronic) synthesizes preclinical data and the FDA IDE clinical trials underlying three regulatory approvals of rhBMP-2/ACS (INFUSE Bone Graft). It covers ALIF spinal fusion (2002), open tibial fractures with IM nail fixation (2004), and sinus/alveolar ridge augmentation (March 2007). The central question: what is the clinical evidence base supporting each approved indication?
Before INFUSE, the only commercially available bone graft substitutes were osteoconductive ceramics — passive scaffolds that require autograft to work and carry no intrinsic bone-forming capacity. Autograft remained the gold standard, despite a 5.9% harvest-site adverse event rate and 32% of patients reporting persistent donor-site pain at 2 years.
This review codifies the three scenarios where you can reach for INFUSE instead of a bone graft harvest: ALIF with LT-CAGE, open tibial fractures stabilized with an IM nail, and sinus/alveolar ridge augmentation. When you use it, 1.5 mg/cc is the target. Both the tibial and sinus trials showed 0.75 mg/cc underperforms.
The most common intraoperative error is overpacking a contained defect. Compressing extra sponge into a small space drives local concentration above 1.5 mg/cc and risks undesired local effects. Match sponge volume to defect volume.
The BESTT trial data (44% reduction in secondary interventions, lower infection in type-III fractures) give you the numbers when counseling trauma patients. And a 41% reoperation rate with IM nailing alone is the baseline that makes this intervention worth considering.
This 2007 narrative review by McKay et al. (Medtronic) synthesizes preclinical data and the FDA IDE clinical trials underlying three regulatory approvals of rhBMP-2/ACS (INFUSE Bone Graft). It covers ALIF spinal fusion (2002), open tibial fractures with IM nail fixation (2004), and sinus/alveolar ridge augmentation (March 2007). The central question: what is the clinical evidence base supporting each approved indication?
Before INFUSE, the only commercially available bone graft substitutes were osteoconductive ceramics — passive scaffolds that require autograft to work and carry no intrinsic bone-forming capacity. Autograft remained the gold standard, despite a 5.9% harvest-site adverse event rate and 32% of patients reporting persistent donor-site pain at 2 years.
This review codifies the three scenarios where you can reach for INFUSE instead of a bone graft harvest: ALIF with LT-CAGE, open tibial fractures stabilized with an IM nail, and sinus/alveolar ridge augmentation. When you use it, 1.5 mg/cc is the target. Both the tibial and sinus trials showed 0.75 mg/cc underperforms.
The most common intraoperative error is overpacking a contained defect. Compressing extra sponge into a small space drives local concentration above 1.5 mg/cc and risks undesired local effects. Match sponge volume to defect volume.
The BESTT trial data (44% reduction in secondary interventions, lower infection in type-III fractures) give you the numbers when counseling trauma patients. And a 41% reoperation rate with IM nailing alone is the baseline that makes this intervention worth considering.