Non-Randomized Controlled Comparative Study of Gene-Activated Osteoplastic Material "Histograft" in Patients With Degenerative Diseases of the Lumbar and Cervical Spine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Adverse events and Severe Adverse Events
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signing the informed consent
- •indications for spinal fusion: degenerative-dystrophic diseases of the cervical and lumbar spine.
排除标准
- •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
结局指标
主要结局
Adverse events and Severe Adverse Events
时间窗: Within 1 year after intervention
Frequency of Adverse and Severe Adverse Events after treatment
Spinal fusion
时间窗: 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)
次要结局
- Unexpected Adverse Drug Reaction(Within 1 year after intervention)
- SF- 36 score (The Short Form-36)(6 and 12 months after treatment)