NCT06365307 - "Comparative Study of Gene-Activated Bone Substitute Histograft for Lumbar and Cervical Spinal Fusion" | Biotech Hunter

Enrollment

300

Participants

Timeline

Start Date

November 13, 2023

Primary Completion Date

September 1, 2024

Study Completion Date

April 30, 2025

Conditions

Cervical Disc Disorder With RadiculopathySpinal StenosisLumbar and Other Intervertebral Disc Disorders With RadiculopathyBiomechanical Lesion, Unspecified

Interventions

COMBINATION_PRODUCT

"Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF (Histograft)"

Due to the localization of the pathological process, all patients are divided into two groups: 1 - cervical spine, 2 - lumbar spine. Within these groups, patients are treated with either gene-activated osteoplastic material Histograft or synthetic osteoplastic material based on β-TCP (β-tricalcium phosphate) for spinal fusion of the cervical spine, or with bone autograft for spinal fusion of the lumbar spine.

OTHER

Synthetic osteoplastic material based on β-TCP or bone autograft

Due to the localization of the pathological process, all patients are divided into two groups: 1 - cervical spine, 2 - lumbar spine. Within these groups, patients are treated with either gene-activated osteoplastic material Histograft or synthetic osteoplastic material based on β-TCP (β-tricalcium phosphate) for spinal fusion of the cervical spine, or with bone autograft for spinal fusion of the lumbar spine.

Trial Locations (1)

117588

RECRUITING

"Scientific Clinical Center No. 2 of Federal State Budgetary Research Institution Russian research center of surgery named after academician B.V.Petrovsky", Moscow