Prospective nonrandomized comparison of an allograft with bone morphogenic protein versus an iliac-crest autograft in anterior cervical discectomy and fusion
ABSTRACT Anterior cervical discectomy and fusion (ACDF) using autogenous iliac bone graft may lead to donor-site morbidity. This has led some surgeons to use alternatives to iliac bone graft, but often the alternatives have greater rates of nonunion and delayed union. Bone morphogenic protein (BMP) studies have found high arthrodesis rates in lumbar fusions.
The objective of this pilot study was to compare the success of BMP combined with bone allograft with iliac bone autograft in ACDF patients.
The institutional review board approved a prospective but nonrandomized study of 66 consecutive patients who had primary one- to three-level ACDF with either iliac-crest bone autograft or BMP allograft (0.9 mg BMP per level) followed prospectively over a 2- to 3-year period.
Consecutive patients who had primary one- to three-level ACDF with either iliac-crest bone autograft (n=36) or BMP-allograft (n=30). Patients in both iliac bone graft and BMP-allograft groups had comparable preoperative pain and disability.
Visual analog scale pain, pain drawing, Oswestry index, pain medication use, opinion of treatment success, and neurological recovery.
Given the nonrandomized nature of the study, the study groups were not matched. Within this limitation, both groups of patients had similar improvement in all outcome scales (visual analog scale pain, pain drawing, Oswestry index, pain medication use, and opinion of treatment success) and neurological recovery over the 2- to 3-year follow-up period. Patients in the iliac bone graft group had two pseudarthroses and two complications of the iliac-crest donor site. In the BMP-allograft group, one patient had a pseudarthrosis, but 50% had neck swelling presenting as dysphagia, which was substantially more common than the 14% present in the iliac bone graft group. Patients in the BMP-allograft group had slightly shorter surgery time, but implant and hospitalization costs were higher.
ACDF performed with BMP (0.9 mg BMP per level) allograft is as effective as iliac bone graft in terms of patient outcomes and fusion rates. Safety concerns related to neck swelling and higher initial costs were associated with patients in the bone morphogenic protein group.
- SourceAvailable from: Brook I. Martin
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- "The figure is annotated by the publication dates of studies by Shields et al. , Pradhan , Lewandrowski et al. , Vaidya et al. , and Buttermann , which were among the first case series to report wound complication, osteolysis, and dysphagia with BMP in anterior cervical fusion. Those by Mindea et al. , Wong et al. , Joseph and Rampersaud , and Carragee et al.  were the first to raise concerns about postoperative radiculitis and retrograde ejaculation with lumbar fusions involving BMP. "
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.The spine journal: official journal of the North American Spine Society 12/2014; 15(4). DOI:10.1016/j.spinee.2014.12.010 · 2.80 Impact Factor
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ABSTRACT: Original collation: xi, 243 leaves. Thesis (Ed. D.)--Indiana University, 1972.
Conference Paper: Technical impact of deregulation in Japan [power industry][Show abstract] [Hide abstract]
ABSTRACT: The Japanese deregulation process started in 1995. Since then, Japan has been faced several challenges related both with the development of the rules and with the implementation of technologies needed to accommodate smoothly restructuring process and guarantee a reliable power system. In this paper, we particularly focus on the business rules, which are applied to Japanese electricity market, and the technologies that were developed in the last two years to support the economic exchange of electricity among players and the new planning, analysis and controlling system for new transmission users.Power System Technology, 2002. Proceedings. PowerCon 2002. International Conference on; 11/2002