protocolSection identificationModule nctId: NCT06365307, orgStudyIdInfo id: Histograft-SF-2023, briefTitle: Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-13, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Histograft Co., Ltd., class: INDUSTRY, collaborators name: Petrovsky National Research Center of Surgery, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the safety and efficacy of the combination product "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene, in spinal fusion prosedure in comparison with bone autografts and synthetic material based on β-TCP, conditionsModule conditions: Cervical Disc Disorder With Radiculopathy, conditions: Spinal Stenosis, conditions: Lumbar and Other Intervertebral Disc Disorders With Radiculopathy, conditions: Biomechanical Lesion, Unspecified, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: During the preliminary screening and indication for surgical treatment, patients are divided into 2 groups depending on the location of the pathological process: 1 - cervical spine, 2 - lumbar spine. During independent sequential randomization in a 1:1 ratio, patients in each of these groups are divided into clinical (A) and control (B) groups.Distribution of treatment methods by groups:1A - use of "Histograft" for spinal fusion of the cervical spine, 50 patients1. B - use of synthetic osteoplastic material based on β-TCP for spinal fusion of the cervical spine, 50 patients2. A - use of "Histograft" for spinal fusion of the lumbar spine, 100 patients2B - use of bone autograft for spinal fusion of the lumbar spine, 100 patients, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft"), interventions name: Synthetic osteoplastic material based on β-TCP or bone autograft, outcomesModule primaryOutcomes measure: Spinal fusion, primaryOutcomes measure: Adverse events and Severe Adverse Events, secondaryOutcomes measure: SF- 36 score (The Short Form-36), secondaryOutcomes measure: Unexpected Adverse Drug Reaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Scientific Clinical Center No. 2 of Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V.Petrovsky", status: RECRUITING, city: Moscow, state: Moscow Oblast, zip: 117588, country: Russian Federation, contacts name: Renat Nurmukhametov, role: CONTACT, email: ethic@med.ru, contacts name: Mark Aleksanyan, role: CONTACT, contacts name: Renat Nurmukhametov, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False