Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion

Launched by HISTOGRAFT CO., LTD. · Apr 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called "Histograft," which is a special type of bone substitute designed to help with spinal fusion surgery. Spinal fusion is a procedure that connects two or more bones in the spine to relieve pain from conditions like cervical disc disorder, spinal stenosis, and other degenerative issues. The trial aims to see how safe and effective Histograft is compared to traditional methods, such as using the patient’s own bone (called autograft) or synthetic materials.

To join this trial, participants need to be between the ages of 65 and 74 and must sign a consent form agreeing to take part. They should have specific problems in their cervical or lumbar spine that require surgery. However, those who have had previous spinal surgery in the same area, are under 18, or have certain serious health conditions won't be eligible. If chosen for the study, participants can expect to undergo the spinal fusion surgery with the Histograft, and their progress will be monitored to ensure safety and effectiveness. This trial is currently looking for volunteers, so it could be an opportunity to help improve treatment options for spinal issues.

Gender

ALL

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