title: Allogeneic morphogenetic protein vs. recombinant human bone morphogenetic protein-2 in lumbar interbody fusion procedures: a radiographic and economic analysis.
abstract: BACKGROUND
  Since the introduction of rhBMP-2 (Infuse) in 2002, surgeons have had an alternative substitute to autograft and its related donor site morbidity. Recently, the prevalence of reported adverse events and complications related to the use of rhBMP-2 has raised many ethical and legal concerns for surgeons. Additionally, the cost and decreasing reimbursement landscape of rhBMP-2 use have required identification of a viable alternative. Osteo allogeneic morphogenetic protein (OsteoAMP) is a commercially available allograft-derived growth factor rich in osteoinductive, angiogenic, and mitogenic proteins. This study compares the radiographic fusion outcomes between rhBMP-2 and OsteoAMP allogeneic morphogenetic protein in lumbar interbody fusion spine procedures.
  
  
  METHODS
  Three hundred twenty-one (321) patients from three centers underwent a transforaminal lumbar interbody fusion (TLIF) or lateral lumbar interbody fusion (LLIF) procedure and were assessed by an independent radiologist for fusion and radiographically evident complications. The independent radiologist was blinded to the intervention, product, and surgeon information. Two hundred and twenty-six (226) patients received OsteoAMP with autologous local bone, while ninety-five (95) patients received Infuse with autologous local bone. Patients underwent radiographs (x-ray and/or CT) at standard postoperative follow-up intervals of approximately 1, 3, 6, 12, and 18 months. Fusion was defined as radiographic evidence of bridging across endplates, or bridging from endplates to interspace disc plugs. Osteobiologic surgical supply costs were also analyzed to ascertain cost differences between OsteoAMP and rhBMP-2.
  
  
  RESULTS
  OsteoAMP produced higher rates of fusion at 6, 12, and 18 months (p ≤ 0.01). The time required for OsteoAMP to achieve fusion was approximately 40% less than rhBMP-2 with approximately 70% fewer complications. Osteobiologic supply costs were 80.5% lower for OsteoAMP patients (73.7% lower per level) than for rhBMP-2.
  
  
  CONCLUSIONS
  Results of this study indicate that OsteoAMP is a viable alternative to rhBMP-2 both clinically and economically when used in TLIF and LLIF spine procedures.
authors.affiliation: Orthopedics International, 12333 NE 130th Lane #400, Kirkland, WA 98034, USA. jeffreyrohmd@gmail.com.
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Roh
authors.forename: Christopher A
authors.initials: CA
authors.lastname: Yeung
authors.forename: Justin S
authors.initials: JS
authors.lastname: Field
authors.forename: R Trigg
authors.initials: RT
authors.lastname: McClellan
mesh_terms: D000328:Adult; D000368:Aged; D055396:Bone Morphogenetic Protein 2 / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D019485:Bone Morphogenetic Proteins / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D016025:Bone Transplantation / Q000379:methods; D016527:Drug Costs / Q000706:statistics & numerical data; D004341:Drug Evaluation / Q000379:methods; D005260:Female; D006801:Humans; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009999:Ossification, Heterotopic / Q000139:chemically induced; D010014:Osteolysis / Q000139:chemically induced; D011859:Radiography; D011994:Recombinant Proteins / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D012189:Retrospective Studies; D016037:Single-Blind Method; D013123:Spinal Fusion / Q000009:adverse effects / Q000379:methods*; D016212:Transforming Growth Factor beta / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins; D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta; C499469:recombinant human bone morphogenetic protein-2