Evaluation of a silica-containing bone graft substitute in a vertebral defect model.

Orthopedic and spine surgeons are in need of supplements or replacements for autograft. We investigated the histological properties of three formulations of Calcium Sodium Phosphosilicate [calcium sodium phosphosilicate putty with or without autograft and NovaBone 45S5 Bioglass particulate (NovaBone, LLC, Jacksonville, FL)] using a sheep vertebral bone void model. Bone voids were surgically created in L3, L4, and L5 in each of 22 sheep, and the voids were filled with one of the tested biomaterials or left empty as a control. Histological evaluations were performed at either: 0, 6, or 12 weeks after surgery. Undecalcified sections were digitized, and the areas of the original defect and new bone were quantified. Decalcified sections were evaluated qualitatively. Histomorphometry showed a significant increase in the amount of bone between 6 and 12 weeks in all groups, but there was no significant difference in new bone formation among the formulations or between any formulation and the empty defects. The granules of all three formulations were associated with an inflammatory reaction. Many of the particles appear to have a hollow center, and the narrow tunnel through the center of the particles was sometimes associated with acute inflammation especially at 6 weeks. These particles were also associated with chronic inflammation at both 6 and 12 weeks, although the extent of inflammation decreased between 6 and 12 weeks. The search for the optimum bone graft substitute/extender will continue.