Many growth factors have been studied as additives accelerating lumbar fusion rates in different animal models. However, their low hydrolytic and thermal stability both in vitro and in vivo limits their workability and use. In the proposed work, a stabilized vasculogenic and prohealing fibroblast growth factor-2 (FGF2-STAB®) exhibiting a functional half-life in vitro at 37 °C more than 20 days was applied for lumbar fusion in combination with a bioresorbable scaffold on porcine models. An experimental animal study was designed to investigate the intervertebral fusion efficiency and safety of a bioresorbable ceramic/biopolymer hybrid implant enriched with FGF2-STAB® in comparison with a tricortical bone autograft used as a gold standard. Twenty-four experimental pigs underwent L2/3 discectomy with implantation of either the tricortical iliac crest bone autograft or the bioresorbable hybrid implant (BHI) followed by lateral intervertebral fixation. The quality of spinal fusion was assessed by micro-computed tomography (micro-CT), biomechanical testing, and histological examination at both 8 and 16 weeks after the surgery. While 8 weeks after implantation, micro-CT analysis demonstrated similar fusion quality in both groups, in contrast, spines with BHI involving inorganic hydroxyapatite and tricalcium phosphate along with organic collagen, oxidized cellulose, and FGF2- STAB® showed a significant increase in a fusion quality in comparison to the autograft group 16 weeks post-surgery (p = 0.023). Biomechanical testing revealed significantly higher stiffness of spines treated with the bioresorbable hybrid implant group compared to the autograft group (p < 0.05). Whilst histomorphological evaluation showed significant progression of new bone formation in the BHI group besides non-union and fibrocartilage tissue formed in the autograft group. Significant osteoinductive effects of BHI based on bioceramics, collagen, oxidized cellulose, and FGF2-STAB® could improve outcomes in spinal fusion surgery and bone tissue regeneration.

CEITEC Central European Institute of Technology Brno University of Technology 612 00 Brno Czech Republic

Department of Composites and Carbon Materials Institute of Rock Structure and Mechanics The Czech Academy of Sciences 182 09 Prague Czech Republic

Department of Mechanics Biomechanics and Mechatronics Faculty of Mechanical Engineering Czech Technical University Prague 160 00 Prague Czech Republic

Department of Paediatric Surgery Orthopedics and Traumatology Faculty of Medicine Masaryk University and The University Hospital Brno 662 63 Brno Czech Republic

Department of Pathology Faculty of Medicine of Masaryk University and The University Hospital Brno 625 00 Brno Czech Republic

Department of Tissue Engineering Institute of Experimental Medicine of the Czech Academy of Sciences Videnska 1083 142 20 Prague Czech Republic

Trauma Surgery Department Faculty of Medicine Masaryk University and The University Hospital Brno 625 00 Brno Czech Republic

University Center for Energy Efficient Buildings Czech Technical University Prague 273 43 Bustehrad Czech Republic

Veterinary Research Institute 621 00 Brno Czech Republic

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A Biological Study of Composites Based on the Blends of Nanohydroxyapatite, Silk Fibroin and Chitosan