title: RhBMP-2 versus iliac crest bone graft for lumbar spine fusion in patients over 60 years of age: a cost-utility study.
abstract: METHODS
  Randomized clinical trial.
  
  
  OBJECTIVE
  To perform a cost-utility analysis using actual cost data from a randomized clinical trial of patients over 60 years old who underwent posterolateral fusion using either rhBMP-2/ACS or iliac crest bone graft (ICBG).
  
  
  BACKGROUND
  Bone morphogenetic protein has been shown to be an effective bone graft substitute for spine fusion. However, a clinical trial-based economic analysis of rhBMP-2/ACS compared with iliac crest bone graft has not been done.
  
  
  METHODS
  Patients over 60 years old requiring decompression and posterolateral fusion were randomized to rhBMP-2/ACS (n = 50) or ICBG (n = 52). A dedicated hospital coder and research nurse tracked each patient to determine direct costs of inpatient care and all postoperative healthcare encounters up to 2 years after surgery. Preoperative and 2-year-postoperative SF-6D utility scores for each patient were determined. A decision tree was created, which included the probability of complications, need for additional treatments and revision surgery; and the costs associated with initial surgery and treatment for complications and additional treatment for continued spine symptoms; and utility scores.
  
  
  RESULTS
  The mean total 2-year cost for care (excluding complication and additional spine treatment costs) was $34,235 in the ICBG group and $36,530 in the rhBMP-2/ACS group. For the entire group, the mean cost to treat a major complication was $10,888, the cost of revision surgery for nonunion was $46,852, and additional treatment for spine-related events was $5892. In the ICBG group, 8 patients had complications; 20 had additional interventions, 5 of whom required revision for nonunion. In the rhBMP-2/ACS group, 6 patients had complications, 10 had additional interventions, and 1 required revision for nonunion. The cost of using rhBMP-2/ACS was $39,967 with a 0.11 mean improvement in SF-6D; and for ICBG the cost was $42,286 with a mean improvement of 0.10 in SF-6D.
  
  
  CONCLUSIONS
  There are more complications, increased need for additional treatment and revision surgery in patients over 60 years old receiving ICBG compared with rhBMP-2/ACS. This may account for higher costs and lower improvements in utility seen in patients receiving ICBG compared with rhBMP-2/ACS in this study population.
authors.affiliation: Kenton D. Leatherman Spine Center, Louisville, KY 40202, USA. lcarreon@spinemds.com
authors.forename: Leah Y
authors.initials: LY
authors.lastname: Carreon
authors.forename: Steven D
authors.initials: SD
authors.lastname: Glassman
authors.forename: Mladen
authors.initials: M
authors.lastname: Djurasovic
authors.forename: Mitchell J
authors.initials: MJ
authors.lastname: Campbell
authors.forename: Rolando M
authors.initials: RM
authors.lastname: Puno
authors.forename: John R
authors.initials: JR
authors.lastname: Johnson
authors.forename: John R
authors.initials: JR
authors.lastname: Dimar
mesh_terms: D000368:Aged; D055396:Bone Morphogenetic Protein 2 / Q000008:administration & dosage / Q000191:economics*; D001861:Bone Regeneration / Q000187:drug effects / Q000502:physiology; D016025:Bone Transplantation / Q000191:economics* / Q000379:methods / Q000706:statistics & numerical data; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003663:Decision Trees; D019299:Decompression, Surgical / Q000191:economics / Q000379:methods; D005260:Female; D017048:Health Care Costs; D006801:Humans; D007405:Intervertebral Disc Displacement / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D007902:Length of Stay; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011859:Radiography; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000191:economics*; D013123:Spinal Fusion / Q000191:economics* / Q000379:methods; D013130:Spinal Stenosis / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D016896:Treatment Outcome
chemical_list: C525718:BMP2 protein, human; D055396:Bone Morphogenetic Protein 2; D011994:Recombinant Proteins