Article

Recombinant Human Bone Morphogenetic Protein-2-Induced Radiculitis in Elective Minimally Invasive Transforaminal Lumbar Interbody Fusions

Department of Neurological Surgery, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.
Spine (Impact Factor: 2.45). 07/2009; 34(14):1480-4; discussion 1485. DOI: 10.1097/BRS.0b013e3181a396a1
Source: PubMed

ABSTRACT Retrospective single center analysis.
The purpose of our study is to quantify the development of a postoperative radiculitis in our minimally invasive transforaminal lumbar interbody fusion patient population.
The application of recombinant human Bone Morphogenetic Protein-2 (BMP) in spinal surgery has allowed for greater success in spinal fusions. This has led to the FDA approving its use in anterior lumbar interbody fusion. However, its well-recognized benefits have generated its "off-label" use in the cervical, thoracic, and lumbar spine. Despite its benefits, the adverse effects of its inflammatory properties are just starting to get recognized. Some clear adverse reactions have been documented in the literature in the cervical spine. However, we feel that these inflammatory properties may be present in the lumbar spine as well.
We performed a retrospective chart review of 43 patients who had undergone a minimally invasive transforaminal lumbar interbody fusions. Thirty-five of these patients had BMP and 8 patients did not have BMP. We documented whether there was a preoperative radiculopathy present and whether a radiculopathy was present postoperative. We reviewed radiographic postoperative imaging to establish a structural cause for any radiculopathy. If new or increasing radicular symptoms were present, we attempted to assess the duration of these symptoms.
Our analysis, showed that 0 of the 8 patients of the non-BMP group had new radicular symptoms that were not attributed to structural causes. In the BMP group, 4 of the 35 patients (11.4%) had new radicular symptoms without structural etiology.
Our analysis suggest that patients undergoing minimally invasive transforaminal lumbar interbody fusions procedures have a higher incidence of developing new radicular symptoms that could be attributed to BMP.

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    ABSTRACT: Use of Bone Morphogenetic Protein (BMP) as an adjunct to spinal fusion surgery proliferated following Food and Drug Administration (FDA) approval in 2002. Major safety concerns emerged in 2008. To examine whether published concerns about the safety of BMP altered clinical practice. Analysis of the National Inpatient Sample from 2002 through 2012. Adults (age >20) undergoing an elective fusion operation for common degenerative diagnoses, identified using codes from the International Classification of Diseases, 9(th)revisions, Clinical Modification (ICD-9-CM). Proportion of cervical and lumbar fusion operations, over time, that involved BMP. We aggregated the data into a monthly time series and reported the proportion of cervical and lumbar fusion operations, over time, that involved BMP. Auto Regressive Integrated Moving Average, a regression model for time series data, was used to test whether there was a statistically significant change in the overall rate of BMP use following a FDA Public Health Notification in 2008. The study was funded by federal research grants, and no investigator had any conflict of interests. Use of BMP in spinal fusion procedures increased rapidly until 2008, involving up to 45.2% of lumbar and 13.5% of cervical fusions. BMP use significantly decreased following the 2008 FDA Public Health Notification and revelations of financial payments to surgeons involved in the pivotal FDA approval trials. For lumbar fusion, the average annual increase was 7.9 percentage points per year from 2002 to 2008, followed by an average annual decrease of 11.7 percentage points thereafter (p = <0.001). Use of BMP in cervical fusion increased 2.0% per year until the FDA Notification, followed by a 2.8% per year decrease (p = 0.035). Use of BMP in spinal fusion surgery declined subsequent to published safety concerns and revelations of financial conflicts-of-interest for investigators involved in the pivotal clinical trials. Copyright © 2014 Elsevier Inc. All rights reserved.
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    • "The clinical availability of rhBMP-2 has had a profound impact on the field of spinal surgery. The ability of rhBMP- 2 to modulate mesenchymal cell differentiation through a complex signaling cascade allows increased osteoblast formation and improved osteogenesis and bone healing [19] [21]. However, this advancement has not occurred without significant adverse side effects [10]. "
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