Preparation of combined β-TCP/α-CSH artificial bone graft and its performance in a spinal fusion model.

To evaluate α-calcium sulfate hemihydrate (α-CSH)/β-tricalcium phosphate (β-TCP) combined artificial bone graft (COB) in an animal model of posterolateral spinal fusion, α-CSH and β-TCP were combined in a 3 : 7 weight ratio. A rabbit model of posterolateral spinal fusion was produced (N = 36); one side was implanted with the COB, and the other with local autogenous bone. Rabbits were killed on the 4th, 8th, or 12th week after surgery and fusion, COB degradation, mineralization, and new bone formation were evaluated. Scanning electron microscopy revealed that the COB retained the porous spatial structure of β-TCP and α-CSH crystals were adhered to the surface and pores of β-TCP. At the 12th week after surgery, the fusion rate was 75.0% on the 12th week after the operation, which was higher than the fusion rate of 54.4% the autogenous bone side (p = 0.073). Bone volume fraction of the COB was 0.49 ± 0.08 for the 4th week and 0.16 ± 0.05 for the 12th week after surgery. The mineralization rate of the new bone was greater on the side implanted with autogenous bone than on the side implanted with COB at all the three time points after surgery. At each time point after surgery, the difference in mineralization rate between the autogenous bone side and the COB side was statistically significant (p < 0.001); α-CSH/β-TCP in a 3 : 7 weight ratio was as effective as local autogenous bone in producing spinal fusion in a rabbit model. Used in this ratio, the speed of material degradation and new bone formation are relatively equivalent, and the rate of new bone mineralization is similar to that of autogenous bone graft.