The Spine Journal
Volume 11, Issue 6 , Pages 471-491 , June 2011

A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned

  • Eugene J. Carragee, MD

      Affiliations

    • Department of Orthopedic Surgery, Stanford Medicine Outpatient Center, Stanford University School of Medicine, 450 Broadway, Mail Code 6342, Redwood City, CA 94063, USA
    • Corresponding Author InformationCorresponding author. Department of Orthopedic Surgery, Stanford Medicine Outpatient Center, Stanford University School of Medicine, 450 Broadway, Mail Code 6342, Redwood City, CA 94063, USA. Tel.: (650) 721-7616; fax: (650) 721-3470.
  • ,
  • Eric L. Hurwitz, DC, PhD

      Affiliations

    • Office of Public Health, University of Hawaii, 1960 East-West Rd, Honolulu, HI, USA
  • ,
  • Bradley K. Weiner, MD

      Affiliations

    • Department of Orthopaedic Surgery, The Methodist Hospital, 6565 Fannin St, Houston, TX, USA

Received 18 February 2011 ,Revised 25 April 2011 ,Accepted 27 April 2011.

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 FDA device/drug status: Some rhBMP-2 uses in this article are approved; others are not. See text for details.

 Author disclosures: EJC: Stock Ownership (options only): Intrinsic Spine, Cytonics, Simpirica (B); Private Investments: Simpirica (D); Consulting: US Department of Justice (D), Kaiser Permanente (D), US Army (Trips/Travel disclosed), US Department of Defense (Trips/Travel disclosed); Research Support (Investigator Salary): NIH (C, Paid directly to institution/employer); Other office: NASS The Spine Journal (E, Editor in Chief); Fellowship Support: OREF (E, Paid directly to institution/employer), AO Foundation (E, Paid directly to institution/employer); Trips/Travel: US Army (B), Department of Defense (A), Orthopedic Trauma Society (A), OREF (B), AAOS (A), NASS (A), The Spine Journal (A). ELH: Nothing to disclose. BKW: Nothing to disclose.

 The disclosure key can be found on the Table of Contents and at www.TheSpineJournalOnline.com.

PII: S1529-9430(11)00299-3

doi: 10.1016/j.spinee.2011.04.023

The Spine Journal
Volume 11, Issue 6 , Pages 471-491 , June 2011