title: rhBMP-2 for posterolateral instrumented lumbar fusion: a multicenter prospective randomized controlled trial.
abstract: METHODS
  Multicenter randomized controlled trial.
  
  
  OBJECTIVE
  To evaluate the effect of recombinant human bone morphogenetic protein (rhBMP-2) on radiographical fusion rate and clinical outcome for surgical lumbar arthrodesis compared with iliac crest autograft.
  
  
  BACKGROUND
  In many types of spinal surgery, radiographical fusion is a primary outcome equally important to clinical improvement, ensuring long-term stability and axial support. Biologic induction of bone growth has become a commonly used adjunct in obtaining this objective. We undertook this study to objectify the efficacy of rhBMP-2 compared with traditional iliac crest autograft in instrumented posterolateral lumbar fusion.
  
  
  METHODS
  Patients undergoing 1- or 2-level instrumented posterolateral lumbar fusion were randomized to receive either autograft or rhBMP-2 for their fusion construct. Clinical and radiographical outcome measures were followed for 2 to 4 years postoperatively.
  
  
  RESULTS
  One hundred ninety seven patients were successfully randomized among the 8 participating institutions. Adverse events attributable to the study drug were not significantly different compared with controls. However, the control group experienced significantly more graft-site complications as might be expected. 36-Item Short Form Health Survey, Oswestry Disability Index, and leg/back pain scores were comparable between the 2 groups. After 4 years of follow-up, radiographical fusion rates remained significantly higher in patients treated with rhBMP-2 (94%) than those who received autograft (69%) (P = 0.007).
  
  
  CONCLUSIONS
  The use of rhBMP-2 for instrumented posterolateral lumbar surgery significantly improves the chances of radiographical fusion compared with the use of autograft. However, there is no associated improvement in clinical outcome within a 4-year follow-up period. These results suggest that use of rhBMP-2 should be considered in cases where lumbar arthrodesis is of primary concern.
authors.affiliation: *University of Calgary Spine Program and Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta †Division of Orthopedic Surgery, Dalhousie University, Halifax, Nova Scotia, Canada ‡Division of Orthopedic Surgery, University of Western Ontario, London, Ontario, Canada §Division of Orthopedic Surgery, University of Alberta, Edmonton, Alberta, Canada ¶Division of Orthopedic Surgery, Dalhousie University, St. John, New Brunswick, Canada ‖Division of Orthopedic Surgery, Trillium Health Centre, Mississauga, Ontario, Canada; **Division of Orthopedic Surgery, University of Montreal, Montreal, Quebec, Canada; and ††Division of Orthopedic Surgery, University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: R John
authors.initials: RJ
authors.lastname: Hurlbert
authors.forename: David
authors.initials: D
authors.lastname: Alexander
authors.forename: Stewart
authors.initials: S
authors.lastname: Bailey
authors.forename: James
authors.initials: J
authors.lastname: Mahood
authors.forename: Ed
authors.initials: E
authors.lastname: Abraham
authors.forename: Robert
authors.initials: R
authors.lastname: McBroom
authors.forename: Alain
authors.initials: A
authors.lastname: Jodoin
authors.forename: Charles
authors.initials: C
authors.lastname: Fisher
mesh_terms: D000293:Adolescent; D000328:Adult; D055396:Bone Morphogenetic Protein 2 / Q000627:therapeutic use*; D019485:Bone Morphogenetic Proteins / Q000627:therapeutic use*; D016025:Bone Transplantation / Q000379:methods; D005260:Female; D006801:Humans; D008159:Lumbar Vertebrae / Q000187:drug effects* / Q000601:surgery; D008161:Lumbosacral Region / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D013123:Spinal Fusion / Q000379:methods; D014182:Transplantation, Autologous / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D055396:Bone Morphogenetic Protein 2; D019485:Bone Morphogenetic Proteins; D011994:Recombinant Proteins