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It is FDA indicated for acute open tibial shaft fracture
16%
352/2141
It is FDA indicated for single level posterolateral lumbar fusions
25%
534/2141
It is cost-effective for posterolateral lumbar fusions when compared to iliac crest bone graft
28%
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It is FDA indicated for single level ALIFs
14%
310/2141
It has a decreased risk of revision surgery when compared to iliac crest bone grafting in posterolateral lumbar fusions
15%
330/2141
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All of the statements listed above are true EXCEPT for answer 2 - BMP-2 is not FDA indicated for single-level posterolateral lumbar fusions. Bone morphogenetic proteins are a member of the TGF-beta superfamily. It is an osteoinductive material that induces mesenchymal stems cells to differentiate into bone-forming osteoblasts. There has been an increasing amount of literature published around its use in long bone procedures, spinal procedures, and nonunions. Currently, the FDA indications for rhBMP-2 are acute open tibial shaft fractures treated within 14 days and single level ALIFs with a lumbar tapered fusion device. Hsu et al. authored a systematic review including 6 articles on the cost-effectiveness of BMP-2 compared to iliac crest bone graft (ICBG) in lumbar and cervical arthrodesis procedures. They conclude that in lumbar arthrodesis procedures BMP-2 is only cost-effective when taking into account societal costs such as productivity and lost wages. Carreon et al. performed a cost-utility analysis on an RCT that they performed comparing BMP-2 to ICBG in posterolateral lumbar fusions. There are more complications, increased need for additional treatment and revision surgery in patients over 60 years old receiving ICBG compared with rhBMP-2/ACS, which account for an increased cost utility for the ICBG group. Glassman et al., in the paper that the aforementioned study worked off of, performed an RCT of rhBMP-2/ACS (Infuse bone graft) versus iliac crest bone graft (ICBG) for lumbar spine fusion in patients over 60 years of age. They conclude that BMP-2 is a viable ICBG replacement in older patients in terms of safety, clinical efficacy, and cost-effectiveness. Cheng et al. looked at the osteogenic activity of fourteen different BMPs on mesenchymal progenitor cells. They found BMP-2, 6, and 9 induced high levels of alkaline phosphatase activity in pluripotent stem cells. They conclude BMP-2, 6, and 9 may play important roles in inducing osteoblast differentiation of mesenchymal stem cells. Illustration A (Cheng et al.) is a figure demonstrating the distinct osteogenic activity of human BMPs. BMP-2, 6, and 9 are the most potent agents to induce osteoblast lineage differentiation of mesenchymal progenitor cells while most BMPs can promote the terminal differentiation of committed osteoblast precursors. Incorrect answers: Answers 1: BMP-2 is currently FDA indicated for acute open tibial shaft fracture. Answers 3: As noted in the literature above, rhBMP-2 has been shown to be cost-effective when utilized for posterolateral fusions in patients over 60 years old when taking into account the societal costs associated with increased need for revision surgery when utilizing ICBG. Answers 4: BMP-2 is currently FDA indicated It is FDA indicated for single level ALIFs Answer 5: As the studies note above, in patients older than 60 years old, the use of ICBG was associated with an increased need for revision surgery
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