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{\u0022basePath\u0022:\u0022\\\/\u0022,\u0022pathPrefix\u0022:\u0022\u0022,\u0022highwire\u0022:{\u0022markup\u0022:[{\u0022requested\u0022:\u0022full-text\u0022,\u0022variant\u0022:\u0022full-text\u0022,\u0022view\u0022:\u0022full\u0022,\u0022pisa\u0022:\u0022spmdc;14\\\/50\\\/30\u0022},{\u0022requested\u0022:\u0022long\u0022,\u0022variant\u0022:\u0022full-text\u0022,\u0022view\u0022:\u0022full\u0022,\u0022pisa\u0022:\u0022spmdc;14\\\/50\\\/30\u0022}],\u0022ac\u0022:{\u0022spmdc;14\\\/50\\\/30\u0022:{\u0022access\u0022:{\u0022reprint\u0022:true,\u0022full\u0022:true},\u0022pisa_id\u0022:\u0022spmdc;14\\\/50\\\/30\u0022,\u0022atom_uri\u0022:\u0022\u0022,\u0022jcode\u0022:\u0022spmdc\u0022}}},\u0022googleanalytics\u0022:{\u0022trackOutbound\u0022:1,\u0022trackMailto\u0022:1,\u0022trackDownload\u0022:1,\u0022trackDownloadExtensions\u0022:\u00227z|aac|arc|arj|asf|asx|avi|bin|csv|doc(x|m)?|dot(x|m)?|exe|flv|gif|gz|gzip|hqx|jar|jpe?g|js|mp(2|3|4|e?g)|mov(ie)?|msi|msp|pdf|phps|png|ppt(x|m)?|pot(x|m)?|pps(x|m)?|ppam|sld(x|m)?|thmx|qtm?|ra(m|r)?|sea|sit|tar|tgz|torrent|txt|wav|wma|wmv|wpd|xls(x|m|b)?|xlt(x|m)|xlam|xml|z|zip\u0022,\u0022trackUrlFragments\u0022:1},\u0022ajaxPageState\u0022:{\u0022js\u0022:{\u0022sites\\\/all\\\/libraries\\\/cluetip\\\/jquery.cluetip.js\u0022:1,\u0022sites\\\/all\\\/libraries\\\/cluetip\\\/lib\\\/jquery.hoverIntent.js\u0022:1,\u0022sites\\\/all\\\/libraries\\\/cluetip\\\/lib\\\/jquery.bgiframe.min.js\u0022:1,\u0022sites\\\/all\\\/modules\\\/highwire\\\/highwire\\\/plugins\\\/highwire_markup_process\\\/js\\\/highwire_at_symbol.js\u0022:1,\u0022sites\\\/all\\\/modules\\\/highwire\\\/highwire\\\/plugins\\\/highwire_markup_process\\\/js\\\/highwire_article_reference_popup.js\u0022:1,\u0022sites\\\/all\\\/modules\\\/contrib\\\/google_analytics\\\/googleanalytics.js\u0022:1,\u00220\u0022:1}}});\n\/\/--\u003E\u003C!]]\u003E\n\u003C\/script\u003E\n\u003Clink type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EBone morphogenetic proteins (BMPs) were used with increasing frequency in spine surgery after 2002, but their use has decreased as concerns have developed about possible cancer risk and complications. In this session, presenters discussed the evidence regarding BMPs and their associated cancer risk, other possible complications, and the patterns of BMP use since 2002.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ESpine Conditions Orthopaedic Procedures\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ESpine Conditions\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOrthopaedics\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EOrthopaedic Procedures\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EBone morphogenetic proteins (BMPs) were used with increasing frequency in spine surgery after 2002, but their use has decreased as concerns have developed about possible cancer risk and complications. In this session, presenters discussed the evidence regarding BMPs and their associated cancer risk, other possible complications, and the patterns of BMP use since 2002.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EBMPS AND CANCER RISK\u003C\/h2\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EWellington K. Hsu, MD, Northwestern University, Evanston, Illinois, USA, first reviewed the usage and function of BMP. Although the use of recombinant human BMP (rhBMP) increased prior to the issuance of a US Food and Drug Administration (FDA) warning [Schultz DG. FDA Public Health Notification. \u003Ca href=\u0022http:\/\/www.fda.gov\/MedicalDevices\/Safety\/AlertsandNotices\/PublicHealthNotifications\/ucm062000.htm\u0022\u003Ehttp:\/\/www.fda.gov\/MedicalDevices\/Safety\/AlertsandNotices\/PublicHealthNotifications\/ucm062000.htm\u003C\/a\u003E. Accessed November 2014], usage dropped more rapidly after a review article suggested increased cancer risk for rhBMP-2 [Carragee EJ et al. \u003Cem\u003ESpine J.\u003C\/em\u003E 2011].\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EDr Hsu stated that although there was no evidence of a mechanism by which BMPs could cause cancer through induction, there was potential that BMPs could cause cancer through promotion (tumorigenesis) or by enabling metastasis. For example, one study showed that BMPs critically influenced the formation of osteoblastic lesions in metastatic prostate cancer [Feely BT et al. \u003Cem\u003EJ Bone Miner Res.\u003C\/em\u003E 2005].\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EDespite the linkage of rhBMP-2 to cancer in a critical review by Carragee and colleagues [\u003Cem\u003ESpine J.\u003C\/em\u003E 2011], Dr Hsu noted that the study had limitations. In particular, the study did not specifically look at the incidence of Surveillance Epidemiology and End Results cancers but rather included all cancers and all stages of cancers. Another study also demonstrated increased cancer risk with AMPLIFY, a high-dose rhBMP-2 product that is not currently approved by the FDA (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). AMPLIFY has a relatively high dose of rhBMP-2 and no dose-dependent effects were noted [Carragee EJ et al. \u003Cem\u003EJ Bone Joint Surg Am.\u003C\/em\u003E 2013]. When a particular agent is associated with cancer, a dose-dependent effect is expected.\u003C\/p\u003E\n         \u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/50\/30\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Comparison of Patients With Cancer Events Using AMPLIFY vs Control\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-2118060481\u0022 data-figure-caption=\u0022Comparison of Patients With Cancer Events Using AMPLIFY vs Control\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/50\/30\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/50\/30\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/50\/30\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15392\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n               \u003Cp id=\u0022p-6\u0022 class=\u0022first-child\u0022\u003EComparison of Patients With Cancer Events Using AMPLIFY vs Control\u003C\/p\u003E\n            \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EAdapted from Carragee EJ et al. Cancer Risk After Use of Recombinant Bone Morphogenetic Protein-2 for Spinal Arthrodesis. \u003Cem\u003EJ Bone Joint Surg Am.\u003C\/em\u003E 2013;95:1537\u20131545. With permission from The Journal of Bone and Joint Surgery, Inc.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-7\u0022\u003ETo summarize these 2 studies, Dr Hsu stated that while there is evidence that AMPLIFY may be linked to cancer, it is not clear how this translates to risks for lower-dose, FDA-approved rhBMP-2 (eg, INFUSE), and it will be important to control for cancer types in future studies.\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EDr Hsu also reviewed data from the Yale University Open Data Access (YODA) Project, in which 2 sites independently reviewed data on rhBMP-2 and cancer risk [Fu R et al. \u003Cem\u003EAnn Intern Med.\u003C\/em\u003E 2013; Simmonds MC et al. \u003Cem\u003EAnn Intern Med.\u003C\/em\u003E 2013]. One group was at the Oregon Health and Science University, Portland, Oregon, USA, while the other was at the University of York, York, United Kingdom. Both sites reported low cancer risks, that Medtronic had underreported risks, and that the cancers seen were heterogeneous. However, only 1 site found an increased risk for cancer at 24 months (RR, 3.45; 95% CI, 1.98 to 6.00). The other site found a nonsignificantly higher cancer rate in the rhBMP-2 group. Dr Hsu described differences in the data analysis (for example, the University of York group excluded pre-existing cancers and 1 trial) that were responsible for these findings and concluded that more research was needed.\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EIn contrast to these results, another study indicated a lower risk for Surveillance, Epidemiology, and End Results cancers [Kelly MP et al. \u003Cem\u003EJ Bone Joint Surg Am.\u003C\/em\u003E 2014]. Dr Hsu noted that other studies have suggested similar results but have limitations (eg, using diagnoses only rather than observations of patients). Thus, it is unclear whether there is a dose-dependent relationship.\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EDr Hsu published a review [\u003Cem\u003EJ Bone Joint Surg Am.\u003C\/em\u003E 2014] with recommendations about when to use rhBMP-2 during spine surgery. He suggested that rhBMP-2 use should be considered on a case-by-case basis, based upon the wishes of the patient following counseling and whether the risk of complications is reasonable. He advises that for patients with a history of cancer, rhBMP-2 use should be avoided.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-3\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EYODA AND RHBMP-2 USAGE\u003C\/h2\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EScott D. Daffner, MD, West Virginia University, Morgantown, West Virgina, USA, presented survey results of about 800 practitioners regarding their use of rhBMP-2. He provided an overview of the results, showing that the most important reasons why clinicians did not use rhBMP-2 included legal concerns, insurance, and a low concern for pseudarthrosis (\u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E).\u003C\/p\u003E\n         \u003Cdiv id=\u0022F2\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/50\/30\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Reasons Practitioners Do Not Use rhBMP-2\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-2118060481\u0022 data-figure-caption=\u0022Reasons Practitioners Do Not Use rhBMP-2\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/50\/30\/F2.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/50\/30\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 2.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/50\/30\/F2.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15393\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 2.\u003C\/span\u003E \n               \u003Cp id=\u0022p-12\u0022 class=\u0022first-child\u0022\u003EReasons Practitioners Do Not Use rhBMP-2\u003C\/p\u003E\n            \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003ErhBMP-2, recombinant human bone morphogenetic protein-2. Reproduced with permission from WK Hsu, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EHe also explained that there was a plateau in BMP use at about 28.3% of spinal fusion procedures beginning in 2008, followed by a 5% decrease in cervical fusions [Mckie J et al. \u003Cem\u003EGlobal Spine J.\u003C\/em\u003E 2014].\u003C\/p\u003E\n         \u003Cp id=\u0022p-14\u0022\u003EHe concluded with an overview of data from North American Spine Society (NASS) members. This illustrated member concerns for different types of complications, with around 60% reporting high concerns regarding cervical swelling and around 80% reporting mild or no concerns regarding cancer and retrograde ejaculation. Additionally, it gave insight into usage patterns and suggested that very few NASS members (0.71% and 2.1% for 2013 and 2014, respectively) had increased rhBMP-2 usage recently.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-4\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EINCIDENCE OF COMPLICATIONS FROM RHBMP-2\u003C\/h2\u003E\n         \u003Cp id=\u0022p-15\u0022\u003EFinally, Michael D. Daubs, MD, University of Nevada, Las Vegas, Nevada, USA, presented data on changes in rhBMP-2 usage over the past 3 years. After reviewing examples of complications, he showed results indicating a great deal of variability in the range of values presented for complications associated with BMP [Mroz TE et al. \u003Cem\u003ESpine (Phila PA 1976)\u003C\/em\u003E. 2010]. This variability raises the question of whether complications were reported accurately, whether there was error, or whether there have been changes in the way that BMP is used. Alternatively, the actual incidence of complications may have changed, potentially due to changes in usage and technique.\u003C\/p\u003E\n         \u003Cp id=\u0022p-16\u0022\u003EThere appear to have been changes in the reported rates of some complications, although Dr Daubs noted that there is a difference in rates from questionnaires vs the laboratory. These changes could reflect changes in reporting rates, reduced occurrence, or changes in actual rates of complications as clinicians have responded to concerns about potential risks of BMPs. He concluded that it is not clear which explanation or combination of explanations is responsible for the changed rates.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2015 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/50\/30.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzltkd\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzltkd\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}