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Randomized Controlled Trial Multicenter Study
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, and Charles Fisher.
- *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 ‡D... more
- Spine. 2013 Dec 1;38(25):2139-48.
Study DesignMulticenter randomized controlled trial.ObjectiveTo 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 DataIn 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.MethodsPatients 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.ResultsOne 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).ConclusionThe 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.
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