A 3D Printed Porous Titanium Alloy Rod with Diamond Crystal Lattice for Treatment of the Early-Stage Femoral Head Osteonecrosis in Sheep.

Abstract

Instruments made of porous titanium alloy and fabricated with a 3D printed technique are increasingly used in experimental and clinical research. To date, however, few studies have assessed their use in early-stage osteonecrosis of the femoral head (ONFH). In this study, porous titanium alloy rods (Ti-Rod) with diamond crystal lattice, fabricated using an electron beam melting (EBM) technique, were implanted into sheep models (n=9) of early-stage ONFH for 6 months. Bone ingrowth and integration were investigated and compared with those of sheep (n=9) undergoing core decompression (CD) alone. Following Ti-Rod implantation, femoral heads showed fine osteointegration, with X-ray evaluation showing compact integration between peripheral bone and rods without radiolucent lines encircling the rods, as well as new bone growth along the metal trabeculae without the intervention of fibrous tissue. The regions of interest (ROIs) of femoral heads showed fine bone ingrowth after Ti-Rod implantation than CD alone. By micro-CT evaluation, the ratios of bone volume to total volume (BV/TV) of ROIs in Rod group was 930 % and 452 % higher than CD group after 3 (0.206 ± 0.0095 vs. 0.020 ± 0.0058, p < 0.05, n=3) and 6 (0.232 ± 0.0161 vs. 0.042 ± 0.0061, p < 0.05, n=3) months respectively. By histological evaluation, the BV/TV of ROIs in Rod group was 647 % and 422 % higher than CD group after 3 (0.157 ± 0.0061 vs. 0.021 ± 0.0061, p < 0.05, n=3) and 6 (0.235 ± 0.0145 vs. 0.045 ± 0.0059, p < 0.05, n=3) months respectively. The new bone grew along metal trabeculae into the center of the rod with a rapid bone ingrowth in Rod gorup. Whereas in CD group, new bone grew mainly at the periphery of the decompressive channel with a slow bone ingrowth. Mechanical analysis showed that maximum load on the femoral head-necks was 31 % greater 6 months after Ti-Rod implantation than after CD alone when the vertical press reached the apex (3751.75 ± 391.96 vs. 2858.25 ± 512.91 N, p < 0.05, n=3). The association of rod implantation with fine bone ingrowth, osteointegration, and favorable mechanical properties suggests that implantation of the porous titanium alloy rod with the diamond crystal lattice may be a beneficial intervention for patients with early-stage ONFH.