Skip Navigation LinksHome > December 01, 2013 - Volume 38 - Issue 25 > rhBMP-2 for Posterolateral Instrumented Lumbar Fusion: A Mul...
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doi: 10.1097/BRS.0000000000000007
Randomized Trial

rhBMP-2 for Posterolateral Instrumented Lumbar Fusion: A Multicenter Prospective Randomized Controlled Trial

Hurlbert, R. John MD, PhD, FRCSC, FACS*; Alexander, David MD; Bailey, Stewart MD, FRCSC; Mahood, James MD, FRCSC§; Abraham, Ed MD, FRCSC; McBroom, Robert MD; Jodoin, Alain MD, FRCSC**; Fisher, Charles MD, FRCSC, MSc††

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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.

Level of Evidence: N/A

© 2013 by Lippincott Williams & Wilkins

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