Clinical trial NCT06365307: Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion
Official title: Non-Randomized Controlled Comparative Study of Gene-Activated Osteoplastic Material "Histograft" in Patients With Degenerative Diseases of the Lumbar and Cervical Spine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Disc Disorder With Radiculopathy
Spinal Stenosis
Lumbar and Other Intervertebral Disc Disorders With Radiculopathy
Biomechanical Lesion, Unspecified
Keywords: Spinal fusion
Bone graft
Lead sponsor: Histograft Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Petrovsky National Research Center of Surgery
First posted: 2024-04-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Spinal fusion
timeFrame: 6 and 12 months after intervention
measure: Adverse events and Severe Adverse Events
timeFrame: Within 1 year after intervention
Secondary outcomes:
measure: SF- 36 score (The Short Form-36)
timeFrame: 6 and 12 months after treatment
measure: Unexpected Adverse Drug Reaction
timeFrame: Within 1 year after intervention
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Scientific Clinical Center No. 2 of Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V.Petrovsky"
state: Moscow Oblast
Study officials:
References: