The Rise and Fall of Bone Morphogenetic Protein 2 Throughout the United States

Abstract

Study Design: Retrospective Database Study. Objective: Investigate utilization of bone morphogenetic protein (BMP-2) between 2004 and 2014. Summary of Background Data: The utilization, particularly off-label utilization, of BMP-2 has been controversial and debated in the literature. Given the concerns regarding cancer and potential complications, the risk benefit profile of BMP must be weighed with each surgical case. The debate regarding the costs and potential side effects of BMP-2 compared with autologous iliac crest bone harvest has continued. Methods: The National Inpatient Sample (NIS) database was queried for the use of BMP-2 (ICD-9-CM 84.52) between 2004 and 2014 across 44 states. The NIS database represents a 20% sample of discharges, weighted to provide national estimates. BMP-2 utilization rates in spine surgery fusion procedures were calculated as a fraction of the total number of thoracic, lumbar, and sacral spinal fusion surgeries performed each year. Results: Between 2004 and 2014, BMP-2 was utilized in 927,275 spinal fusion surgeries. In 2004, BMP-2 was utilized in 28.3% of all cases (N=48,613). The relative use of BMP-2 in spine fusion surgeries peaked in 2008 at 47.0% (N=112,180). Since then, it has continued to steadily decline with an endpoint of 23.6% of cases in 2014 (N=60,863). Conclusions: Throughout the United States, the utilization of BMP-2 in thoracolumbar fusion surgeries increased from 28.3% to 47.0% between 2004 and 2008. However, from 2008 to 2014, the utilization of BMP-2 in thoracolumbar spine fusion surgeries decreased significantly from 47.0% to 23.4%. While this study provides information on the utilization of BMP-2 for the entire United States over an 11-year period, further research is needed to the determine the factors affecting these trends.

Current Trends in Recombinant Human Bone Morphogenetic Protein 2 (rhBMP2) Usage for Spinal Fusion Surgery

“…Respondents may have been more likely to participate due to being advocates for rhBMP2 usage, or they may be individuals who are staunchly against the off-label use. We did observe a response rate of 20.5%, which is similar to prior studies [ 14 ]. Furthermore, the relatively low number of respondents is a limitation of this study.…”

“…Hofstetter et al found that the frequency of complications from rhBMP-2 rose with increasing dosages used [ 13 ]. Importantly, the rate of rhBMP-2 use in the United States has been reported to be declining steadily since 2008, possibly due to the reports of possible associated adverse effects [ 14 ].…”

Metal ions: the unfading stars of bone regeneration—from bone metabolism regulation to biomaterial applications

“…7,8 However, the application of these growth factors remains limited and challenging due to high prices, the control of physiological doses, and poor clinical outcomes. 9,10…”

Optimal Strategies for the Treatment of Osteoporotic Spinal Diseases

“…Because the quality of autograft in osteoporosis patients is poor, other bone substitutes have been adopted for spine fusion, such as allograft, demineralized bone matrix, and growth factors. Recombinant human bone morphogenic protein 2 (BMP-2) stimulates bone growth through a number of pathways, including stimulation of mesenchymal stem cell differentiation down an osteoblastic lineage, and now has become the important surgical option, especially in severe osteoporotic patients [ 6 , 7 ]. Many studies have demonstrated the utility of recombinant human BMP-2 (rhBMP-2) in enhancing fusion rates, so the use of rhBMP-2 has expanded in an off-label manner for various spinal fusion surgeries to assist with fusion in severe osteoporosis patients.…”

“…Recombinant human bone morphogenic protein 2 (BMP-2) stimulates bone growth through a number of pathways, including stimulation of mesenchymal stem cell differentiation down an osteoblastic lineage, and now has become the important surgical option, especially in severe osteoporotic patients. 6,7 Many studies have demonstrated the utility of recombinant human BMP-2 (rhBMP-2) in enhancing fusion rates, so the use of rhBMP-2 has expanded in an off-label manner for various spinal fusion surgeries to assist with fusion in severe osteoporosis patients. However, there is a significant relation between the dose of rhBMP-2 use and the complication rates.…”