Comparison of a novel oxysterol molecule and rhBMP2 fusion rates in a rabbit posterolateral lumbar spine model

Abstract Background context The nonunion rate after lumbar spinal fusion is as high as 25%. Recombinant human bone morphogenetic protein 2 (rhBMP2) has been used as a biological adjunct to promote bony fusion. However, recently there have been concerns about BMP2. Oxysterol 133 (Oxy133) has been shown to promote excellent fusion rates in rodent lumbar spine models and offers a potential alternative to rhBMP2. Purpose The purpose of this study was to compare the fusion rate of rhBMP2 and Oxy133 in a randomized controlled trial using a posterolateral lumbar rabbit spinal fusion model. Study design This was a randomized control animal study. Methods Twenty-four male adult white New Zealand rabbits (3–3.5 kg) underwent bilateral posterolateral lumbar spinal fusion at L4–L5. Rabbits were divided into four groups: control (A), 30-μg rhBMP2 (B), 20-mg Oxy133 (C), and 60-mg Oxy133 (D). At 4 weeks, fusion was evaluated by fluoroscopy, and at 8 weeks, the rabbits were sacrificed and fusion was evaluated radiographically, by manual palpation, and with microcomputed tomography. Results Fusion rates by radiographic analysis at 8 weeks were Group A, 40.0%; Group B, 91.7%; Group C, 91.7%; and Group D, 100%. Evaluation of fusion masses by manual palpation of excised spines after sacrifice showed the following fusion rates: Group A, 0%; Group B, 83.3%; Group C, 83.3%; and Group D, 90%. Microcomputed tomography scanning confirmed these findings. Conclusions These findings in a rabbit model demonstrate that both 20- and 60-mg Oxy133 doses promote fusion that is equivalent to fusion induced by 30-μg rhBMP2 and significantly greater than the control group. The present findings confirm that Oxy133 is a promising candidate for therapeutic development as an alternative to rhBMP2 to promote spinal fusion.