Study design: The ability of hydroxyapatite (HA) materials to enhance the fixation strength of posterior spinal instrumentation was examined in 19 adult mongrel dogs.
Methods: Sixteen dogs underwent bilateral placement of lumbar transpedicular screws from L1 to L6, sacral alar screws, and posterior iliac rods. The six transpedicular screw test groups included standard and plasma-sprayed HA-coated screws with the recommended insertion technique, standard and HA-coated screws with a poor initial fit insertion technique using an oversized pilot hole, and HA-grout augmentation of standard and HA-coated screws with a poor initial fit. The sacral alar screws and posterior iliac rods were either uncoated or HA-coated. Six dogs were killed immediately; ten dogs were killed at 6 weeks, and the fixation elements were mechanically tested or histologically examined. Three additional dogs and synthetic bone material were used for additional baseline mechanical testing.
Results: The strength of standard screws with recommended insertion did not change after 6 weeks in vivo. HA-coated screws were initially 13% less resistant to pull out than standard screws, but this difference was not significant at 6 weeks. Screws inserted with a poor initial fit technique were significantly weaker initially; at 6 weeks, pull-out strength was similar to the standard screws properly inserted. The HA-grout material significantly enhanced pull-out strength for both screw types at 6 weeks. Sacral alar screw pull-out strength was not significantly different between standard and HA-coated screws initially or at 6 weeks. HA-coated rods were initially twice as resistant to pull out than standard rods and became stronger after 6 weeks in vivo, whereas standard rods became significantly weaker. Histologically, the quantity and morphology of bone around all implants was similar, with HA-coated rods and screws demonstrating regions of direct attachment to bone. An osteoconductive response and new bone formation was observed within the HA-grout material. Scanning electron microscopic observation of mechanically tested implants revealed a shear failure of surrounding bone (and HA if present) at the screw outer thread margin or at the bone-metal or HA-metal interfaces for the posterior iliac rods.
Conclusions: The strength of poorly inserted transpedicular screws was significantly enhanced in vivo by the resorbable HA-grout material. The lower strength of HA-coated screws was attributed to screw geometry changes resulting from the coating process, and modifications of screw coating are recommended.