Injectable Bone Substitute Based on β-TCP Combined With a Hyaluronan-Containing Hydrogel Contributes to Regeneration of a Critical Bone Size Defect Towards Restitutio ad Integrum.

Abstract

In the present in vivo study, the regenerative potential of a new injectable bone substitute (IBS) composed of beta-tricalcium phosphate (β-TCP) and hyaluronan was tested in a rabbit distal femoral condyle model. To achieve this, 2 defects of 6 mm in diameter and 10 mm in length were drilled into each femur condyle in a total of 12 animals. For each animal, 1 hole was filled with the substitute material, and the other was left empty to serve as the control. After 1, 3, and 6 months, the regenerative process was analyzed by radiography as well as by histological and histomorphometrical analysis. The results revealed that bone tissue formation took place through osteoconductive processes over time, starting from the defect borders to the center. Both the β-TCP content and the hydrogel support bone tissue growth. The histomorphometrical measurements showed that the amount of bone formation in the experimental group was significantly higher compared with that found in the control group after 3 months (19.51 ± 5.08% vs. 1.96 ± 0.77%, P < .05) and 6 months (4.57 ± 1.56% vs. 0.23 ± 0.21%, P < .05). The application of the IBS gave a restitutio ad integrum result after 6 months and was associated with its nearly complete degradation, in contrast to the results found in the control group. In conclusion, the results of the present study demonstrate that the IBS contributes to sufficient bone regeneration by serving as a scaffold-like structure, combined with its degradation within 6 months.