Working Paper Article Version 1 This version is not peer-reviewed

Effectiveness and Feasibility of Injectable Escherichia coli-Derived Recombinant Human Bone Morphogenetic Protein-2 on Anterior Lumbar Interbody Fusion at Lumbosacral Junction For Adult Spinal Deformity: A Clinical Pilot Study

Version 1 : Received: 27 December 2020 / Approved: 28 December 2020 / Online: 28 December 2020 (12:06:09 CET)

How to cite: Im, S.; Lee, K.Y.; Lim, H.S.; Yoo, S.; Lee, J. Effectiveness and Feasibility of Injectable Escherichia coli-Derived Recombinant Human Bone Morphogenetic Protein-2 on Anterior Lumbar Interbody Fusion at Lumbosacral Junction For Adult Spinal Deformity: A Clinical Pilot Study. Preprints 2020, 2020120692 Im, S.; Lee, K.Y.; Lim, H.S.; Yoo, S.; Lee, J. Effectiveness and Feasibility of Injectable Escherichia coli-Derived Recombinant Human Bone Morphogenetic Protein-2 on Anterior Lumbar Interbody Fusion at Lumbosacral Junction For Adult Spinal Deformity: A Clinical Pilot Study. Preprints 2020, 2020120692

Abstract

Achievement of solid fusion of the lumbosacral junction (L5-S1 level) is an important factor in adult spinal deformity (ASD) surgery. The purpose of this study is to explore the effectiveness and feasibility of injectable rhBMP-2 (a combination of Eschericia coli-derived rhBMP-2 and hydrogel type β-TCP carrier; NOVOSIS Inject) as a bone substitute for the fusion of lumbosacral junction. 20 patients (average age 69.1 years) diagnosed with ASD with sagittal imbalance who underwent surgical treatment including anterior lumbar interbody fusion (ALIF) in the L5-S1 level were evaluated. Injectable rhBMP-2 was applied in L5-S1 ALIF and followed-up for 1-year. Solid fusion rates and changes of clinical outcomes (Oswestry Disability Index [ODI], Visual Analog Scale [VAS] of back and leg) were measured and analyzed at 6 and 12 months after surgery. All postoperative adverse events were evaluated about the association with injectable rhBMP-2. Fusion rates were 68.4% and 100% at 6 and 12 months after surgery. Compared to baseline, ODI were improved to 45.8% and 63.7%, VAS(back) were improved to 69.2% and 72.8%, and VAS(leg) were improved to 49.2% and 64.8% at 6 and 12 months after surgery (p<0.001, respectively). There were no adverse events associated with injectable rhBMP-2. Thus, injectable rhBMP-2 may be a suitable choice of a bone graft substitute when achieving solid interbody fusion in the lumbosacral junction.

Keywords

adult spinal deformity; lumbosacral junction; anterior lumbar interbody fusion; bone morphogenetic protein; beta-tricalcium phosphate

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