Background: Uncemented implants are still associated with several major challenges, especially with regard to their manufacturing and their osseointegration. In this study, a novel manufacturing technique—an optimized form of precision casting—and a novel surface modification to promote osseointegration—calcium and phosphorus ion implantation into the implant surface—were tested in vivo. Methods: Cylindrical Ti6Al4V implants were inserted bilaterally into the tibia of 110 rats. We compared two generations of cast Ti6Al4V implants (CAST 1st GEN, n = 22, and CAST 2nd GEN, n = 22) as well as cast 2nd GEN Ti6Al4V implants with calcium (CAST + CA, n = 22) and phosphorus (CAST + P, n = 22) ion implantation to standard machined Ti6Al4V implants (control, n = 22). After 4 and 12 weeks, maximal pull-out force and bone-to-implant contact rate (BIC) were measured and compared between all five groups. Results: There was no significant difference between all five groups after 4 weeks or 12 weeks with regard to pull-out force (p > 0.05, Kruskal Wallis test). Histomorphometric analysis showed no significant difference of BIC after 4 weeks (p > 0.05, Kruskal–Wallis test), whereas there was a trend towards a higher BIC in the CAST + P group (54.8% ± 15.2%), especially compared to the control group (38.6% ± 12.8%) after 12 weeks (p = 0.053, Kruskal–Wallis test). Conclusion: In this study, we found no indication of inferiority of Ti6Al4V implants cast with the optimized centrifugal precision casting technique of the second generation compared to standard Ti6Al4V implants. As the employed manufacturing process holds considerable economic potential, mainly due to a significantly decreased material demand per implant by casting near net-shape instead of milling away most of the starting ingot, its application in manufacturing uncemented implants seems promising. However, no significant advantages of calcium or phosphorus ion implantation could be observed in this study. Due to the promising results of ion implantation in previous in vitro and in vivo studies, further in vivo studies with different ion implantation conditions should be considered.
(1) In order to enable a more widespread use of uncemented titanium-based endoprostheses to replace cobalt-containing cemented endoprostheses for joint replacement, it is essential to achieve optimal osseointegrative properties and develop economic fabrication processes while retaining the highest biomedical quality of titanium materials. One approach is the usage of an optimized form of Ti6Al4V-precision casting for manufacturing. Besides the chemical and physical properties, it is necessary to investigate possible biological influences in order to test whether the new manufacturing process is equivalent to conventional methods. (2) Methods: Primary human osteoblasts were seeded on discs, which were produced by a novel Ti6Al4V centrifugal-casting process in comparison with standard machined discs of the same titanium alloy. In a second step, the surfaces were modified by calcium or phosphorus ion beam implantation. In vitro, we analyzed the effects on proliferation, differentiation, and apoptotic processes. (3) Results: SEM analysis of cells seeded on the surfaces showed no obvious differences between the reference material and the cast material with or without ion implantation. The MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) proliferation assay also did not reveal any significant differences. Additionally, the osteogenic differentiation process tested by quantitative polymerase chain reactions (PCR), Alizarin red S assay, and C-terminal collagen type I propeptide (CICP) Elisa was not significantly modified. No signs of induced apoptosis were observed. (4) Conclusions: In this study, we could show that the newly developed process of centrifugal casting generated a material with comparable surface features to standard machined Ti6Al4V material. In terms of biological impact on primary human osteoblasts, no significant differences were recognized. Additional Ca- or P-ion implantation did not improve or impair these characteristics in the dosages applied. These findings indicate that spin casting of Ti6Al4V may represent an interesting alternative to the production of geometrically complex orthopedic implants.
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