rhBMP-2 for posterolateral instrumented lumbar fusion: A multicenter prospective randomized controlled trial

R. John Hurlbert, David Alexander, Stewart Bailey, James Mahood, Ed Abraham, Robert Mcbroom, Alain Jodoin, Charles Fisher

Research output: Contribution to journalArticlepeer-review

27 Scopus citations

Abstract

STUDY DESIGN.: 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. SUMMARY OF BACKGROUND DATA.: 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). CONCLUSION.: 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.

Original languageEnglish (US)
Pages (from-to)2139-2148
Number of pages10
JournalSpine
Volume38
Issue number25
DOIs
StatePublished - Dec 1 2013
Externally publishedYes

Keywords

  • BMP
  • arthrodesis
  • bone graft
  • degenerative disc disease
  • degenerative disease
  • osteoinduction
  • spine
  • stability

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine
  • Clinical Neurology

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