A newly-published study will likely raise more questions about the growing use of bone morphogenetic protein (BMP) in spinal fusion surgeries, The study, published in the February 1 issue of the journal Spine, examined the use of BMP for spinal fusion surgery in older patients with lumbar stenosis, and found that while the bone growth protein increased costs, its use was not associated with better outcomes for patients.
The U.S. Food & Drug Administration (FDA) approved BMP for use in 2002 in one type of spinal fusion procedure, anterior lumbar interbody fusion. One of the more well-known BMP products on the market is Medtronic Inc.’s Infuse bone growth product, also known as recombinant human Bone Morphogenetic Protein-2 or BMP2.
BMP stimulates bone growth naturally in the human body. When used in spinal surgery, BMP can create a fusion without the need for any use of the patient’s own bone. It is not fully understood how BMP’s work or what other side effects they may produce. The Spine study is the first to look how BMP affects the outcomes of spinal fusion for patients in routine care (as opposed to clinical trials).
The Spine study analyzed Medicare data from 2002 to 2008, to identify trends related to the use of BMP in spinal fusion surgery among adults with lumbar stenosis (narrowing of the spinal canal in the lower back),. The study authors found that the use of BMP in these types of surgeries has increased dramatically since it was approved in 2002. In 2003, BMP was only used in 5.5 percent of procedures, but by 2008 its use had jumped to 28.1 percent. BMP was most often used in people who needed more complex spinal fusion procedures.
While the study did not note an increase in complications between people who received BMP and those who underwent a traditional procedure, the use of BMP did not reduce the need for repeat surgery. In both groups, about three percent of patients underwent repeat surgery within one year, and six percent at two years. Similar rates were seen in patients undergoing more complex spinal fusion procedures with and without BMP.
Use of BMP also made spinal fusion far more expensive, with researchers noting an average increase of $15,000 in hospital charges.
“[The] results suggest that BMP may add substantial cost to fusion procedures, with little improvement in subsequent reoperation rates,” the study authors wrote.