Comparing a new bone substitute for spinal fusion
Non-Randomized Controlled Comparative Study of Gene-Activated Osteoplastic Material "Histograft" in Patients With Degenerative Diseases of the Lumbar and Cervical Spine
NA · Histograft Co., Ltd. · NCT06365307
This study is testing a new bone substitute called Histograft to see if it helps people with spine problems heal better after surgery compared to other options.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Histograft Co., Ltd. (industry) |
| Locations | 1 site (Moscow, Moscow Oblast) |
| Trial ID | NCT06365307 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of 'Histograft', a gene-activated bone substitute, in spinal fusion procedures for patients with cervical and lumbar spine disorders. Participants will be divided into groups receiving either Histograft, bone autograft, or synthetic material based on β-TCP. The primary outcomes will focus on the bone fusion rate assessed through computer tomography at 6 and 12 months, while safety will be monitored by tracking adverse events throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include adults with degenerative-dystrophic diseases of the cervical and lumbar spine requiring spinal fusion.
Not a fit: Patients with a history of spinal surgery in the area of planned fusion or those with chronic diseases in decompensated forms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective alternative to traditional bone grafts for spinal fusion.
How similar studies have performed: Other studies have shown promise with similar gene-activated approaches, but this specific application of Histograft is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Moscow, Moscow Oblast
- Scientific Clinical Center No. 2 of Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V.Petrovsky" — Moscow, Moscow Oblast, Russian Federation (RECRUITING)
Study contacts
- Study coordinator: Renat Nurmukhametov
- Email: ethic@med.ru
- Phone: +7(965)437-8946
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cervical Disc Disorder With Radiculopathy, Spinal Stenosis, Lumbar and Other Intervertebral Disc Disorders With Radiculopathy, Biomechanical Lesion, Unspecified, Spinal fusion, Bone graft