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| Name | Class |
|---|---|
| Petrovsky National Research Center of Surgery | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical group | Experimental | Group of patients, who is treated with usage of Histograft bone substitute (gene-activated matrix based on octacalcium phosphate and plasmid DNA encoding VEGFA gene) in spinal fusion of cervical or lumbal spine |
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| Control group | Active Comparator | Group of patients, who get standard treatment with usage of synthetic osteoplastic material based on β-TCP for spinal fusion of the cervical spine or use of bone autograft for spinal fusion of the lumbar spine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft") | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Spinal fusion | 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) | 6 and 12 months after intervention |
| Adverse events and Severe Adverse Events | Frequency of Adverse and Severe Adverse Events after treatment | Within 1 year after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| SF- 36 score (The Short Form-36) | Assessment of life quality. A score value is ranging from 0 to 100. Higher scores indicate better health status | 6 and 12 months after treatment |
| Unexpected Adverse Drug Reaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renat Nurmukhametov | Contact | +7(965)437-8946 | ethic@med.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientific Clinical Center No. 2 of Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V.Petrovsky" | Recruiting | Moscow | Moscow Oblast | 117588 | Russia |
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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
2B - use of bone autograft for spinal fusion of the lumbar spine, 100 patients
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| Synthetic osteoplastic material based on β-TCP or bone autograft | Other | 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. |
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Identification of Unexpected Adverse Drug Reaction
| Within 1 year after intervention |
|
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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