Injectability of a bone filler system based on hydroxyapatite microspheres and a vehicle with in situ gel‐forming ability

Abstract

The aim of this study was to test the injectability of a bone filler system based on the combination of ceramic microspheres with a gel-like vehicle, for noninvasive surgery. Porous hydroxyapatite microspheres with a uniform size and an average diameter of 535 +/- 38 mum were prepared, and their compression strength and friability were tested. The sodium-alginate solution with a concentration of 7.25% (w/v) was used as the vehicle. To promote its in situ gelation, calcium carbonate and D-gluconic-delta-lactone were added to the solution. Microspheres were mixed with the vehicle at different percentages (20-40 wt %). Gelation times in the range of 8-20 min, were obtained, depending on the formulation. Mixtures of HAp microspheres with alginate solution at 7.25% originating a gel in 11 min present an adequate handling time to perform an injection. Their injectability was evaluated using an injection device commonly employed in vertebroplasty surgical procedures, coupled to a texturometer in compression mode. Using an extrusion rate of 0.1 mm/s, the force required to extrude any of the mixtures tested was lower than 100 N. For an extrusion rate of 1 mm/s mixtures with 40 wt % of microspheres were very difficult to inject. Mixtures with 35 wt % of microspheres presented the best compromise between injectability and compression strength of the gelled system. MicroCT analysis revealed a homogeneous distribution of the microspheres inside the vehicle, as well as full interconnection of the intra-microspheres spaces. The compression strength for the gelled systems ranged from 80 kPa (gel itself) to 600 kPa (composite with 40 wt % of microspheres).