title: Adverse Events With the Use of rhBMP-2 in Thoracolumbar and Lumbar Spine Fusions: A 9-Year Institutional Analysis.
abstract: METHODS
  Retrospective chart review.
  
  
  OBJECTIVE
  To describe the adverse outcomes associated with the use of rhBMP-2 in thoracolumbar and lumbar fusions.
  
  
  BACKGROUND
  rhBMP-2 has been increasingly used in spinal fusions over the past decade. Early studies reported that the use of rhBMP-2 is associated with decreased operative time, blood loss, and pain scores, as well as improved fusion rates. Recent investigations have shown rhBMP-2 to be associated with various complications occurring at incidences ranging from 0% to 100%.
  
  
  METHODS
  Using the institutional electronic medical records, we retrospectively reviewed all patients between January 2002 and September 2010 that underwent thoracolumbar and lumbar spine fusion with BMP. Patient demographics, operative, and outcome/complication information was collected.
  
  
  RESULTS
  A total of 547 patient charts were reviewed with a mean follow-up time of 17 months. Mean age was 58 years. Forty-one percent of patients had undergone previous spine surgery. Thirty-nine percent of patients had a PLIF/TLIF, 29% underwent a PLF, and 20% an ALIF. No relevant differences in the patient characteristics and complications were identified between the various surgical approaches. For all approaches, having undergone a previous spine surgery was associated with increased incidence of radiculitis, reoperation, and pseudoarthrosis (P=0.005, 0.0008, 0.05, respectively) as compared with those without previous spine surgery. Being a current smoker at the time of operation was associated with increased rate of radiculitis (P=0.03) as compared with nonsmokers.
  
  
  CONCLUSIONS
  The use of rhBMP-2, in this study, had an incidence of radiculitis, pseudoarthrosis, and reoperation that was similar to the rates in historical controls without rhBMP-2. Complications do not differ by surgical approach, but are more likely in current smokers and those undergoing revision surgery. A prospective study is warranted to further delineate the adverse event profile of rhBMP-2 and the variables that are likely to affect it (ie, type of surgery, carrier, and dose).
authors: *Cleveland Clinic Center for Spine Health, Cleveland Clinic †Cleveland Clinic Lerner College of Medicine ‡Department of Neurological Surgery, Cleveland Clinic §Department of Neurosurgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania ¶Case Western Reserve University School of Medicine ∥MetroHealth Medical Center #Department of Quantitative Health Sciences, Cleveland Clinic **Case Western Reserve University, Cleveland, OH.
authors: Daniel
authors: D
authors: Lubelski
authors: Kalil G
authors: KG
authors: Abdullah
authors: Michael P
authors: MP
authors: Steinmetz
authors: Matthew D
authors: MD
authors: Alvin
authors: Amy S
authors: AS
authors: Nowacki
authors: Srita
authors: S
authors: Chakka
authors: Edward C
authors: EC
authors: Benzel
authors: Thomas E
authors: TE
authors: Mroz
mesh_terms: D000328:Adult; D000368:Aged; D055396:Bone Morphogenetic Protein 2 / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D011843:Radiculopathy / Q000453:epidemiology / Q000209:etiology; D011994:Recombinant Proteins / Q000009:adverse effects* / Q000627:therapeutic use; D012086:Reoperation; D012189:Retrospective Studies; D012907:Smoking / Q000009:adverse effects; D013123:Spinal Fusion / Q000379:methods*; D013904:Thoracic Vertebrae / Q000601:surgery*; D016896:Treatment Outcome
chemical_list: D055396:Bone Morphogenetic Protein 2; D011994:Recombinant Proteins