Bone Regeneration in SLS-Manufactured Resorbable 3D-Scaffolds-An Experimental Pilot Study in Minipigs.

Background: The aim of this experimental pilot study was to evaluate the effect of pore volume and material composition on bone ingrowth into a resorbable poly-L-lactide-CaCO₃/CaP scaffold. Methods: Cylindric scaffolds of 7 mm diameter and 5 mm height and two different degrees of porosity were produced using selective laser sintering of poly-L-lactide-powder containing 24% CaCO₃ spherulites with and without surface modification with 4% CaP. Six minipigs received the four types of macroporous cylindrical scaffolds, inserted press fit into trephine defects of the tibial metaphyses, and left to heal for 4 and 13 weeks in three animals each. The specimens were evaluated using µCT for pore volume fill, and histomorphometry for bone formation and immunohistochemistry for expression of osteocalcin. Results: After 4 weeks, newly formed bone ranged from 2.73 mm² to 5.28 mm² mean total area. Mean pore volume fill varied between 12.25% and 20.35% and the average level of osteocalcin expression ranged from 2.49 mm² to 4.48 mm² mean total area. No significant differences were found between the different scaffolds. After 13 weeks, bone formation and pore fill volume had significantly increased in all scaffold groups up to a mean value of 14.79 mm² and 96.04%, respectively. Again, differences between the groups were not significant. Conclusions: The tested SLS produced scaffolds allowed for bone ingrowth, almost completely filling the pore volume after 13 weeks. Newly formed bone was in direct contact with the scaffold walls. Differences in pore volume did not account for significant differences in bone formation inside the scaffolds. The addition of CaP likewise did not lead to increased bone formation, most likely due to low availability of CaP to the biological environment.