title: Use of bone morphogenetic protein among patients undergoing fusion for degenerative diagnoses in the United States, 2002 to 2012.
abstract: BACKGROUND
  Use of bone morphogenetic protein (BMP) as an adjunct to spinal fusion surgery proliferated after Food and Drug Administration (FDA) approval in 2002. Major safety concerns emerged in 2008.
  
  
  OBJECTIVE
  The purpose of this study was to examine whether published concerns about the safety of BMP altered clinical practice.
  
  
  METHODS
  The study design involved the analysis of the National Inpatient Sample from 2002 through 2012.
  
  
  METHODS
  Adults (older than 20 years) undergoing an elective fusion operation for common degenerative diagnoses were identified using codes from the International Classification of Diseases, ninth revision, Clinical Modification.
  
  
  METHODS
  Outcome measures were proportion of cervical and lumbar fusion operations, over time, that involved BMP.
  
  
  METHODS
  We aggregated the data into a monthly time series and reported the proportion of cervical and lumbar fusion operations, over time, that involved BMP. Autoregressive 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 after an FDA Public Health Notification in 2008.
  
  
  RESULTS
  Use of BMP in spinal fusion procedures increased rapidly until 2008, involving up to 45.2% of lumbar and 13.5% of cervical fusions. Bone morphogenetic protein use significantly decreased after the 2008 FDA Public Health Notification and revelations of financial payments to surgeons involved in the pivotal FDA-approved 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≤.001). Use of BMP in cervical fusion increased 2.0% per year until the FDA Public Health Notification, followed by a 2.8% per year decrease (p=.035).
  
  
  CONCLUSIONS
  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.
authors.affiliation: The Dartmouth Institute for Health Policy and Clinical Practice, 35 Centerra Parkway, Lebanon, NH 03766, USA; Department of Orthopaedic Surgery Dartmouth-Hitchcock Medical Center, One Medical Center Dr., Lebanon, NH 03756, USA. Electronic address: Brook.I.Martin@Dartmouth.edu.
authors.forename: Brook I
authors.initials: BI
authors.lastname: Martin
authors.affiliation: The Dartmouth Institute for Health Policy and Clinical Practice, 35 Centerra Parkway, Lebanon, NH 03766, USA; Department of Orthopaedic Surgery Dartmouth-Hitchcock Medical Center, One Medical Center Dr., Lebanon, NH 03756, USA; Department of Medicine, Dartmouth-Hitchcock Medical Center, One Medical Center Dr., Lebanon, NH 03756, USA.
authors.forename: Jon D
authors.initials: JD
authors.lastname: Lurie
authors.affiliation: The Dartmouth Institute for Health Policy and Clinical Practice, 35 Centerra Parkway, Lebanon, NH 03766, USA; Department of Community and Family Medicine. Dartmouth-Hitchcock Medical Center, One Medical Center Dr, Lebanon, NH 03756, USA.
authors.forename: Anna N A
authors.initials: AN
authors.lastname: Tosteson
authors.affiliation: Department of Family Medicine, Oregon Health and Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239, USA; Department of Medicine, Oregon Health and Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239, USA; Department of Public Health & Preventive Medicine, Oregon Health and Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239, USA.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Deyo
authors.affiliation: Department of Neurosurgery, Virginia Mason Medical Center, 1100 9th Ave., Mail Stop X7-NS, Seattle, WA 98111, USA.
authors.forename: Farrokh R
authors.initials: FR
authors.lastname: Farrokhi
authors.affiliation: Department of Medicine, Dartmouth-Hitchcock Medical Center, One Medical Center Dr., Lebanon, NH 03756, USA.
authors.forename: Sohail K
authors.initials: SK
authors.lastname: Mirza
mesh_terms: D019485:Bone Morphogenetic Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D002574:Cervical Vertebrae / Q000601:surgery*; D006801:Humans; D008159:Lumbar Vertebrae / Q000601:surgery*; D013122:Spinal Diseases / Q000601:surgery*; D013123:Spinal Fusion / Q000379:methods* / Q000639:trends; D016896:Treatment Outcome; D014481:United States
chemical_list: D019485:Bone Morphogenetic Proteins
keywords: Bone morphogenetic proteins; Epidemiology; Nationwide inpatient sample; Spinal fusion; Surgical safety; rhBMP-2