Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion

An open-label non-randomized controlled clinical trial will be conducted with two groups of patients. Following enrollment based on specific indication criteria, all patients will undergo surgical treatment (spinal fusion) using either bone substitute "Histograft" (for spinal fusion of cervical and lumbar spine) or bone autograft (for spinal fusion of lumbar spine), or synthetic material based on β-TCP (for spinal fusion of cervical spine). The primary outcomes will involve the bone fusion rate evaluated with computer tomography (CT) at 6 and 12 months. For the safety assessment, the frequency of serious adverse events (SAEs) and adverse events (AEs) will be monitored throughout the entire clinical trial.