An interventional study of Spinal Fusion and SurgiFill™ in Spinal Fusion Acquired and Fusion of Spine (Disease), sponsored by Cellontech Co., Ltd.. Completed at 2 sites in South Korea. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Cellontech Co., Ltd. · Not applicable, Interventional, and Treatment
This study was designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with spinal fusion.
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).
1,327 studies on the registry are indexed under Disease; 596 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 732 interventional studies indexed under Disease.
Browse Disease studies →Cellontech Co., Ltd. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In one side of one patient, autogenous bones and SurgiFill™ will be grafted; and in the other side, only the autogenous bones will be grafted.
Procedure: Spinal Fusion · Device: SurgiFill™
In one side of one patient, autogenous bones and SurgiFill™ will be grafted; and in the other side, only the autogenous bones will be grafted.
Procedure: Spinal Fusion
Spinal fusion, also known as spondylodesis or spondylosyndesis, is a surgical technique used to join two or more vertebrae. Supplementary bone tissue, from the patient (autograft), is used in conjunction with the body's natural bone growth (osteoblastic) processes to fuse the vertebrae. 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 study group site, SurgiFill™ and the autogenous bone mixture shall be transplanted, whereas in the control group site, only the autogenous bone shall be transplanted. The autogenous bones are from iliac part.
Also known as: Spinal Fusion, spondylodesis, spondylosyndesis, bone graft
SurgiFill™ is a gel-type high-purity ateolcollagen for bone grafting. SurgiFill™ is used with autogenous iliac graft for dorsolateral spinal fusion.
Volume change of bony fusion mass in the CT
A CT scan shall be conducted one week, and six and 12 months, post-operatively to calculate and record the bone integration volume. The changes in the bone integration volume shown in the CT images shall be compared and analyzed. In other words, the mean values of the experiment group's bone integration volume shown in CT images 1week, six and 12 months post-operatively shall be compared and analyzed.
Time frame: 1week, 6month, and 12month
Degree change of bony fusion mass in the X-ray
A radiography shall be conducted one, three, six, and 12 months post-operatively, and at the additional unscheduled visits, and the PIs from different institutions (i.e., the Seoul St. Mary's PI and the Daejon St. Mary's PI) shall cross-evaluate the results. The mean values of the experiment group's surgical site bone integration level shown in X-ray images one, three, six and 12 months post-operatively shall be compared and analyzed.
Time frame: 1month, 3month, 6month, and 12month
Value of ROI(Region of interest) in the SPECT/CT
The osteoblastic activity levels at the surgical sites of the experiment and control groups shall be compared at three months post-operatively.
Time frame: 3month
VAS Score change of Back pain questionnaire
The level of the pain (i.e., the lumbar pain and the pain radiating to the upper and lower extremities) shall be recorded using the VAS before the spondylodesis, and at six and 12 months post-operatively.
Time frame: screening, 6month and 12 month
ODI Score change of Back pain questionnaire
Using the ODI score from the ODQ, the disturbances in the daily activities associated with the lumbar pain shall be compared before the spondylodesis, and at six and 12 months post-operatively.
Time frame: screening, 6month and 12 month
Number of abnormal blood test result of participants with adverse events as a measure of safety
Regardless of the clinical trial, if there are blood tests' results of participants with adverse events such as hematologic examination (WBC, RBC, Hemoglobin(Hb), Hematocrit(Hct), Platelet(PLT), ESR) and general chemistry (BUN, Creatinine(Cr), AST, ALT, CRP) closed to the day of regular visit, they shall be recorded on the CRF at screening or after spinal fusion. If there is any abnormality of the results, the number of abnormal blood test result will be recorded, and then additionally the result shall be analyzed according to the investigator's judgment.
Time frame: up to 12month
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cellontech Co., Ltd.