title: Change in Off-Label Use of Bone Morphogenetic Protein in Spine Surgery and Associations with Adverse Outcome.
abstract: Study DesignRetrospective cohort study.ObjectiveThe U.S. Food and Drug Administration issued a warning in 2008 against off-label bone morphogenetic protein (BMP-2) use. We aimed to determine (off-label) BMP-2 use in two periods and associations with complications.MethodsWe included 340,393 patients undergoing spinal fusions from the Premier Perspective database (2006 to 2012). BMP-2 use was determined from billing in 2006 to 2008 versus 2009 to 2012. Outcomes included revisions, length of hospital stay (LOHS), and cost of hospital stay (COH). Multilevel regressions measured associations between BMP-2 and outcomes; odds ratios (ORs) and 95% confidence intervals (CIs) are reported.ResultsBMP-2 use decreased from 18.7% in 2006 to 11.5% in 2012. Off-label use remains but is decreasing, particularly for cervical anterior (5.1 versus 2.0%) and cervical posterior procedures (15.3 versus 8.5%; bothp< 0.01 comparing 2006 to 2008 with 2009 to 2012). BMP-2 remains associated with increased LOHS (median 2 versus 3 days; both periods) and COH (median $15,455 versus $27,881 in 2006 to 2008; $17,007 versus $30,331 in 2009 to 2012). Adjusted ORs for the association between BMP-2 and adverse outcomes were generally lower in 2009 to 2012 compared with 2006 to 2008. Most notably, we demonstrate lower ORs for revision after cervical fusions in 2009 to 2012 (OR 1.67, CI 1.01 to 2.78) compared with 2006 to 2008 (OR 2.43, CI 1.66 to 3.54).ConclusionsUsing a previously untapped data source, we show decreased (off-label) BMP-2 use in spinal fusions, particularly in cervical fusions. Although there was a tendency of decreased odds in 2009 to 2012, higher resource utilization and odds for complications remain in patients using BMP-2. A national registry or prospective observational studies will benefit the ongoing discussion.
authors: Department of Population Health Science and Policy, Institute for Healthcare Delivery Science, Icahn School of Medicine at Mount Sinai, New York, New York, United States.
authors: Jashvant
authors: J
authors: Poeran
authors: Department of Anesthesiology, Hospital for Special Surgery, New York, New York, United States.
authors: Mathias
authors: M
authors: Opperer
authors: Department of Population Health Science and Policy, Institute for Healthcare Delivery Science, Icahn School of Medicine at Mount Sinai, New York, New York, United States.
authors: Rehana
authors: R
authors: Rasul
authors: Department of Population Health Science and Policy, Institute for Healthcare Delivery Science, Icahn School of Medicine at Mount Sinai, New York, New York, United States.
authors: Madhu
authors: M
authors: Mazumdar
authors: Department of Orthopedic Surgery, Hospital for Special Surgery, New York, New York, United States.
authors: Federico P
authors: FP
authors: Girardi
authors: Department of Orthopedic Surgery, Hospital for Special Surgery, New York, New York, United States.
authors: Alexander P
authors: AP
authors: Hughes
authors: Department of Anesthesiology, Hospital for Special Surgery, New York, New York, United States.
authors: Stavros G
authors: SG
authors: Memtsoudis
authors: Department of Neurosurgery, Albert Ludwig University of Freiburg, Freiburg, Germany.
authors: Vassilios
authors: V
authors: Vougioukas
keywords: bone morphogenetic protein; complications; off-label; resource utilization; spinal fusion; time trends