Osteoinductive activity of ErhBMP-2 after anterior cervical diskectomy and fusion with a ß-TCP interbody cage in a goat model.

Bone morphogenetic protein (BMP)-2 induces bone and cartilage tissue formation. Large amounts of BMP-2 are difficult to purify or to produce in vitro using eukaryotic cells. The goal of the present study was to assess the clinical use of Escherichia coli-derived recombinant human BMP-2 (ErhBMP-2) on bone fusion after cervical and lumbar spine surgery in a goat model, compared with the standard autogenous iliac bone grafting. Thirty-six goats were randomized to 3 groups: (A) autogenous iliac bone grafting, (B) cervical interbody fusion cage containing ß-tricalcium phosphate (ß-TCP), or (C) cervical interbody fusion cage containing ß-TCP+ErhBMP-2 (2.5 mg). Cervical bone repair was evaluated using radiographs and computed tomography scans at 0, 3, and 6 months. Histological analyses were performed on cervical samples. Two goats died from infection. The differences in intervertebral height among the groups were not significant 3 months postoperatively but became significant after 6 months between groups A vs B and C (P=.04); there was no difference between groups B and C at 6 months. Adding ErhBMP-2 significantly increased cervical fusion at 6 months (P=.04). Histological examinations showed that ß-TCP+ErhBMP-2 increased new bone area, material degradation rate, and depth of tissue penetration and decreased residual material area, all in a time-dependent manner. Escherichia coli-derived rhBMP-2 combined with an enhanced fusion cage containing ß-TCP induced bone formation in a goat model. Furthermore, its ability to promote bone fusion was similar to autogenous iliac bone grafting.