Use of bone morphogenetic protein among patients undergoing fusion for degenerative diagnoses in the United States, 2002 to 2012

Brook I. Martin, Jon D. Lurie, Anna N A Tosteson, Richard (Rick) Deyo, Farrokh R. Farrokhi, Sohail K. Mirza

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Background context 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. Purpose The purpose of this study was to examine whether published concerns about the safety of BMP altered clinical practice. Study design/setting The study design involved the analysis of the National Inpatient Sample from 2002 through 2012. Patient sample 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. Outcome measures 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.

Original languageEnglish (US)
Pages (from-to)692-699
Number of pages8
JournalSpine Journal
Volume15
Issue number4
DOIs
StatePublished - Apr 1 2015

Fingerprint

Bone Morphogenetic Proteins
United States Food and Drug Administration
Spinal Fusion
Public Health
Safety
Outcome Assessment (Health Care)
Drug Approval
Conflict of Interest
International Classification of Diseases
Inpatients
Research Personnel
Clinical Trials

Keywords

  • Bone morphogenetic proteins
  • Epidemiology
  • Nationwide inpatient sample
  • rhBMP-2
  • Spinal fusion
  • Surgical safety

ASJC Scopus subject areas

  • Clinical Neurology
  • Surgery

Cite this

Use of bone morphogenetic protein among patients undergoing fusion for degenerative diagnoses in the United States, 2002 to 2012. / Martin, Brook I.; Lurie, Jon D.; Tosteson, Anna N A; Deyo, Richard (Rick); Farrokhi, Farrokh R.; Mirza, Sohail K.

In: Spine Journal, Vol. 15, No. 4, 01.04.2015, p. 692-699.

Research output: Contribution to journalArticle

Martin, Brook I. ; Lurie, Jon D. ; Tosteson, Anna N A ; Deyo, Richard (Rick) ; Farrokhi, Farrokh R. ; Mirza, Sohail K. / Use of bone morphogenetic protein among patients undergoing fusion for degenerative diagnoses in the United States, 2002 to 2012. In: Spine Journal. 2015 ; Vol. 15, No. 4. pp. 692-699.
@article{e1602de758ed4e0988fad405cbd39513,
title = "Use of bone morphogenetic protein among patients undergoing fusion for degenerative diagnoses in the United States, 2002 to 2012",
abstract = "Background context 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. Purpose The purpose of this study was to examine whether published concerns about the safety of BMP altered clinical practice. Study design/setting The study design involved the analysis of the National Inpatient Sample from 2002 through 2012. Patient sample 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. Outcome measures 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.",
keywords = "Bone morphogenetic proteins, Epidemiology, Nationwide inpatient sample, rhBMP-2, Spinal fusion, Surgical safety",
author = "Martin, {Brook I.} and Lurie, {Jon D.} and Tosteson, {Anna N A} and Deyo, {Richard (Rick)} and Farrokhi, {Farrokh R.} and Mirza, {Sohail K.}",
year = "2015",
month = "4",
day = "1",
doi = "10.1016/j.spinee.2014.12.010",
language = "English (US)",
volume = "15",
pages = "692--699",
journal = "Spine Journal",
issn = "1529-9430",
publisher = "Elsevier Inc.",
number = "4",

}

TY - JOUR

T1 - Use of bone morphogenetic protein among patients undergoing fusion for degenerative diagnoses in the United States, 2002 to 2012

AU - Martin, Brook I.

AU - Lurie, Jon D.

AU - Tosteson, Anna N A

AU - Deyo, Richard (Rick)

AU - Farrokhi, Farrokh R.

AU - Mirza, Sohail K.

PY - 2015/4/1

Y1 - 2015/4/1

N2 - Background context 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. Purpose The purpose of this study was to examine whether published concerns about the safety of BMP altered clinical practice. Study design/setting The study design involved the analysis of the National Inpatient Sample from 2002 through 2012. Patient sample 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. Outcome measures 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.

AB - Background context 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. Purpose The purpose of this study was to examine whether published concerns about the safety of BMP altered clinical practice. Study design/setting The study design involved the analysis of the National Inpatient Sample from 2002 through 2012. Patient sample 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. Outcome measures 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.

KW - Bone morphogenetic proteins

KW - Epidemiology

KW - Nationwide inpatient sample

KW - rhBMP-2

KW - Spinal fusion

KW - Surgical safety

UR - http://www.scopus.com/inward/record.url?scp=84925384474&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84925384474&partnerID=8YFLogxK

U2 - 10.1016/j.spinee.2014.12.010

DO - 10.1016/j.spinee.2014.12.010

M3 - Article

C2 - 25523380

AN - SCOPUS:84925384474

VL - 15

SP - 692

EP - 699

JO - Spine Journal

JF - Spine Journal

SN - 1529-9430

IS - 4

ER -