Non-Randomized Controlled Comparative Study of Gene-Activated Osteoplastic Material "Histograft" in Patients With Degenerative Diseases of the Lumbar and Cervical Spine
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Disc Disorder With Radiculopathy
- Sponsor
- Histograft Co., Ltd.
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Adverse events and Severe Adverse Events
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Adverse events and Severe Adverse Events
Time Frame: Within 1 year after intervention
Frequency of Adverse and Severe Adverse Events after treatment
Spinal fusion
Time Frame: 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)
Secondary Outcomes
- Unexpected Adverse Drug Reaction(Within 1 year after intervention)
- SF- 36 score (The Short Form-36)(6 and 12 months after treatment)