Six spine surgeons discuss trends in the use of bone morphogenetic proteins in spinal surgery.
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Question: What are some key trends for BMP use in spinal care?
Ace Tabaraee, MD. Spine and Trauma Surgeon at Stanislaus Orthopaedics and Doctors Medical Center (Modesto, Calif.): BMP has been one of the most polarizing but effective developments in the world of spine surgery. My indications center around surgical situations where there is poor or insufficient access to local autograft. Some specific on-and off-label use of BMP in my practice include biological supplementation of anterior interbody arthrodesis, minimal invasive transforaminal interbody arthrodesis and biological supplementation (or augmentation) in patients undergoing either revision arthrodesis or three-column osteotomies. Given the plethora of evidence in the literature of BMP, it is very important to clearly explain and document the specific risks and benefits of using this osteopromotive allograft.
Michael S. Hisey, MD. Orthopedic Spine Surgeon at Texas Back Institute (Plano): BMP use has decreased locally due to a few factors. Firstly, insurance has specifically denied surgeries because BMP was planned to be used, and this is also true for cell-based bone grafts. Secondly, there is an increased awareness of specific complications, including postoperative radiculitis. Finally, the availability of alternatives to accelerate healing, including implants and bone graft substitutes with surface features or geometries that induce bone healing, [have negatively affected BMP use].
Richard Kube, MD. Founder and CEO of Prairie Spine & Pain Institute (Peoria, Ill.): I think that usage is certainly regional. In our area of Illinois, I believe that the usage is significantly down. I have not personally used BMP for a few years. I believe that as newer instrumentation strategies and other biologics become available, the usage will continue to be modified.
Brian R. Gantwerker, MD. Founder of the Craniospinal Center of Los Angeles: The future of BMP is a little uncertain. A new Medtronic study examining PLIF and other indications for this adjunct will be critical. The initial enthusiasm has really cooled since. In my practice, I use it for osteoporosis patients as well as pseudoarthrosis/revisions. Used judiciously, it is a critical arrow in our surgical quivers. It will always have a role in spinal surgery.
Vladimir Sinkov, MD. Spine Surgeon at New Hampshire Orthopaedic Center (Nashua): BMP was widely adopted in spine fusions after the initial release, but the concerns about potential side effects, including higher risk of cancers, really blunted its use several years ago. Since then the material has [been] studied further and the increased risk of malignancy was shown to be a lot smaller than initially feared, and we learned how to mitigate the other risks better (such as heterotopic bone formation or bone resorption, postoperative soft tissue inflammation and nerve root irritation).
The use of BMP is now once again on the rise, as more and more surgeons are turning to MIS fusion procedures. Recently, more on-label indications have been released and will drive further increase in the use of BMP for spinal fusions.
James P. Burke, MD, PhD. Chief of Neurosurgery at UPMC Altoona (Pa.): While BMP has been considered to be the most effective alternative to autologous iliac crest bone graft, its cost and recent literature demonstrating a high risk of complications have caused my practice to curtail its use. I use Infuse solely on thoraco/lumbar cases, not in cervical cases, and try to weigh the costs and benefits when using it for the more challenging cases, for example, in long-fusion constructs, extensive revisions and at-risk patients — smokers, some osteoporotics. I still believe that Infuse is a good tool in the appropriate cases, but use it much more sparingly than before.
At the same time, I am always looking for a better, less expensive graft extender that can help me to achieve a more solid arthrodesis. This is especially true in those older patients with lesser bone quality or those who have had a prior laminectomy, limiting the available volume of local autograft. With the exception of BMP, the commercially available bone graft substitutes — allograft bone, synthetic ceramics, demineralized bone, calcium phosphates — are intended to be bone void fillers, with little to no spine indications and no level 1 IDE studies.
I recently started using i-FACTOR as that graft-extender for my interbody cervical and lumbar cages, which includes ALIF, XLIF and P/TLIF procedures as well as for some posterolateral fusions in the cervical, thoracic and lumbar spine. The cost and complication profiles of i-FACTOR are much more attractive than those of BMP, and IDE level 1 studies with two-year follow-up have been completed showing high fusion rates with superiority to autograft in interbody fusion cases. Besides Infuse, i-FACTOR is the only PMA-approved bone graft for spine and the only drug/device combination for spine. So far, my results have been promising, with no device-related complications and early evidence of fusion on standard radiographs out to six months in follow-up.
The development of biologics to enhance spinal fusion is one of the biggest scientific advancements in spine surgery and has the added benefit of eliminating the morbidity of chronic pain from harvesting iliac crest bone grafting. For spine surgeons, balancing cost containment with risk-benefit analyses to achieve optimal patient outcomes adds to our list of responsibilities to our patients.