Efficacy and Safety of SurgiFill™ on Spinal Fusion

Fusion of Spine (Disease) Clinical Trial

Official title: Clinical Trial to Evaluate the Efficacy and Safety of SurgiFill™ on Spinal Fusion -Comparison Between Autograft Mixed With SurgiFill™ and Autograft in Spinal Fusion-

Status Recruiting

Clinical Trial Summary

This study was designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with spinal fusion.

Clinical Trial Description

This study is an open-trial study. The study will be explained to the subjects and they voluntarily agreed to participate in it. Their eligibility to participate in the study will be checked, either the right or left side of one patient will be selected for the study group, and the other, for the control group, through randomization. In the area for the study group, autogenous bones and SurgiFillTM will be grafted; and in the area for the control group, only the autogenous bones will be grafted. They will be asked to follow the guidelines of the investigators during the study and to visit the hospital seven times, including for screening. At each visit, the subjects undergo an examination with doctors, a CT scan, a X-ray, and a SPECT/CT procedure to evaluate the safety and efficacy of SurgiFill™. (*If the subject gets surgery on the screening date, the total number of his or her visits will be six). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fusion of Spine (Disease)
• Spinal Fusion Acquired

• NCT number: NCT02466048
• Study type: Interventional
• Source: Sewon Cellontech Co., Ltd.
• Contact: Hyun Jo Kim, Bachelor
• Phone: 822-460-3237
• Email: angel@swcell.com
• Status: Recruiting
• Phase: Phase 4
• Start date: August 2013
• Completion date: January 2016