This study was aimed to investigate in vitro and in vivo behavior of a Ti6Al7Nb biomaterial with a nanostructured HA-type coating and also the design and realization of a new special knee implant together with a selection of a suitable animal model for preclinical experimentation of the implants.
The metallic material used like substrate alloy for layer deposition was a Ti6Al7Nb alloy obtained by double electron beam melting furnace. In order to obtain a nano-crystalline HA-coating first sodium titanate layer was obtained on the surface and then the implant was immersed in Ringer solution with additional PAW1 biovitroceramic (particles under 20 μm). Different deposition times (5, 10 and 19 days) were employed. Microscopy analysis and corrosion tests of the implants relieves that the nanostructured HA layer after 19 days of immersion shows promising results as regarding the implant employ in preclinical experiments.
After a complex design based on knee bone radiography there has been manufactured two different types of devices for the metallic implants: a metallic plate and a pin. Two plates and two pins were implanted in each animal.
For in vivo experiments the chosen animal model was the mini-pig because of its strong chirurgical resistance and perfect anesthesia toleration. For the testing 10 animals were used for implantation and one for the control. When the plate is implanted the bone has to have a good blood supply after the cut in order to avoid bone to die. All experimented implants were maintained in the animal during six months and periodically inspected. No sign of infection or another problem were observed during this period.