Abstract
Introduction
Porous surfaces developed over the past decades have been shown to promote tissue ingrowth. Hydroxyapatite (HA) coatings have been added to these porous coatings in an attempt to further augment bone ingrowth. The development of additive manufacturing techniques has allowed for precision in building these complex porous structures. The effect of supplemental HA coatings on these new surfaces is unclear. The purpose of this study is to evaluate the biological fixation of a novel 3D printed porous implant in a canine model. In addition, we evaluated the effect of different HA coatings on this 3D printed implant.
Methods
A canine transcortical model was used to evaluate the performance of three different laser rapid manufacturing (LRM) Ti6Al4V cylindrical implants (5.2 mm diameter, 10mm length): LRM with precipitated hydroxyapatite (P-HA), LRM with plasma sprayed hydroxyapatite (PS-HA), and a hydroxyapatite-free control (No-HA). The implants were 50–60% porous with a mean pore size of 450 μm and have a random interconnected architecture with irregular pore sizes and shapes that are designed based on the structure of cancellous bone. A lateral approach to the femoral diaphysis was used to prepare 5 mm unicortical, perpendicular drill holes in 12 canines. One of each implant type was press-fit into each femur. The femora were harvested at both 4 and 12 weeks post implantation, radiographed and prepared for either mechanical push-out testing to assess the shear strength of the bone-implant interface (left femora, N=6) or for histological processing (right femora, N=6). An un-paired Student's t-test was used to compare statistical significance between the 4 and 12-week results, as well as differences due to implant type; p<0.05 was considered significant.
Results
The post-mortem contact radiographs demonstrated substantial condensation of bone around the implants at both 4 and 12 weeks. Bone ingrowth in the canine femora was observed in all implants, with and without HA, at both time periods under backscattered SEM. The mean extent of bone ingrowth at 4 weeks for no-HA, P-HA, and PS-HA implants was 41.5% (95% CI 32.5 to 50.6), 51.0% (95% CI 45.2 to 56.8) and 53.2% (95% CI 41.6 to 64.7), respectively. The mean extent of bone ingrowth at 12 weeks for no-HA, P-HA, and PS-HA implants was 64.4% (95% CI 61.5 to 67.3), 59.9% (95% CI 51.9 to 67.8) and 64.9% (95% CI 58.2 to 71.6), respectively. There was no significant difference in the amount of bone ingrowth between the HA and non-HA coated implants at any of the time points.
All the implants were successfully pushed out after 4 weeks of implantation. The mean shear strength from the push-out test at 4 weeks for the no-HA, P-HA, and PS-HA implants was calculated to be 21.6 MPa (95% CI 17.2 to 26.0), 20.7 MPa (95% CI 18.9 to 22.4), and 20.2 MPa (95% CI 16.3 to 24.2), respectively. At week 12, in two femora all three implant types had compressive failure before rupture of the bone-implant interface with a load of over 2000N. This suggests that the values of shear strength were higher than those calculated from the successful tests at 12 weeks. The mean shear strength for the remaining no-HA, P-HA and PS-HA implants at 12 weeks was calculated to be 39.9 MPa (95% CI 29.8 to 50.9), 33.7 MPa (95% CI 26.3 to 41.2), and 36.0 MPa (95% CI 29.53 to 42.4), respectively. For all implants, the mean shear strength at 12 weeks was statistically significantly greater than at 4 weeks (p<0.05). There was no significant difference in the shear strength between HA coated and non-HA coated implants at 4 or 12 weeks.
Conclusion
At 4 and 12 weeks, all non-HA coated LRM Ti6Al4V implants consistently exhibited very high bone ingrowth and mechanical shear strength in the canine model. These results demonstrate that this novel additive manufactured porous implant promoted biological fixation in a canine model. There was no significant improvement in the extent of bone ingrowth with the addition of HA. This is in agreement with the literature indicating that topography is the dominant factor governing bone apposition to hydroxyapatite-coated implants. It is likely that in this model, the morphologic features and roughness of the surface of the LRM implants stimulated osteoblastic activity, so that the addition of HA had a non-significant effect.
