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. 2014 Sep;7(3):189-92.
doi: 10.1007/s12178-014-9220-4.

A Review and Analysis of the YODA Trials: What Can We Glean Clinically?

Affiliations

A Review and Analysis of the YODA Trials: What Can We Glean Clinically?

Michael E Le et al. Curr Rev Musculoskelet Med. 2014 Sep.

Abstract

Medtronic's biologic, Infuse (rhBMP-2), was approved by the FDA in 2002. Since its approval, a whirlwind of controversy developed culminating in an investigation by the Senate Finance committee. These events led to a landmark agreement between Medtronic and Yale University to perform a comprehensive and unbiased analysis of all patient related data. The project was named the Yale Open Data Access (YODA). The purpose of this article is to evaluate the results of the YODA project and determine what is clinically meaningful.

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References

    1. Ong KL, Villarraga ML, Lau E, Carreon LY, Kurtz SM, Glassman SD. Off-label use of bone morphogenetic proteins in the United States using administrative data. Spine. 2010;35:1794–1800. doi: 10.1097/BRS.0b013e3181ecf6e4. - DOI - PubMed
    1. Shields LB, Raque GH, Glassman SD, Campbell M, Vitaz T, Harpring J, et al. Adverse effects associated with high-dose recombinant human bone morphogenetic protein-2 use in anterior cervical spine fusion. Spine. 2006;31:542–547. doi: 10.1097/01.brs.0000201424.27509.72. - DOI - PubMed
    1. Schultz D. FDA Public Health Notification: Life-threatening complications associated with recombinant human bone morphogenetic protein in cervical spine fusion. FDA. July, 2008. www.fda.gov
    1. Carragee EJ, Hurwitz EL, Weiner BK. A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. Spine J. 2011;11:471–491. doi: 10.1016/j.spinee.2011.04.023. - DOI - PubMed
    1. Fu R, Selph S, McDonagh M, Peterson K, Tiwari A, Chou R, et al. Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion: a systematic review and meta-analysis. Ann Intern Med. 2013;158:890–902. doi: 10.7326/0003-4819-158-12-201306180-00006. - DOI - PubMed

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