Biomechanical Lesion, Unspecified, Cervical Disc Disorder With Radiculopathy, Lumbar and Other Intervertebral Disc Disorders With Radiculopathy, Spinal Stenosis
Conditions
Keywords
Spinal fusion, Bone graft
Brief summary
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
Detailed description
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.
Interventions
COMBINATION_PRODUCTOsteoplastic 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.
OTHERSynthetic 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.
Sponsors
Petrovsky National Research Center of Surgery
Histograft Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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 patients 1. B - use of synthetic osteoplastic material based on β-TCP for spinal fusion of the cervical spine, 50 patients 2. A - use of Histograft for spinal fusion of the lumbar spine, 100 patients 2B - use of bone autograft for spinal fusion of the lumbar spine, 100 patients
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* signing the informed consent * indications for spinal fusion: degenerative-dystrophic diseases of the cervical and lumbar spine.
Exclusion criteria
* refusal to sign IP * age less than 18 years * history of spinal surgery in the area of planned spinal fusion * decompensated forms of chronic diseases * oncological diseases with identified metastases or risk of metastasis * patient's refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spinal fusion | 6 and 12 months after intervention | Vertebral fusion: formation of a bone block according to CT data (regenerated bone density between the vertebrae without areas of fibrosis and signs of resorption around metal structures) |
| Adverse events and Severe Adverse Events | Within 1 year after intervention | Frequency of Adverse and Severe Adverse Events after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF- 36 score (The Short Form-36) | 6 and 12 months after treatment | Assessment of life quality. A score value is ranging from 0 to 100. Higher scores indicate better health status |
| Unexpected Adverse Drug Reaction | Within 1 year after intervention | Identification of Unexpected Adverse Drug Reaction |
Countries
Russia
Contacts
Primary ContactRenat Nurmukhametov
Outcome results
None listed