Fusion of Spine (Disease), Spinal Fusion Acquired
Conditions
Keywords
spinal fusion, bone graft, collagen
Brief summary
This study was designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with spinal fusion.
Detailed 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).
Interventions
PROCEDURESpinal 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.
DEVICESurgiFill™
SurgiFill™ is a gel-type high-purity ateolcollagen for bone grafting. SurgiFill™ is used with autogenous iliac graft for dorsolateral spinal fusion.
Sponsors
Sewon Cellontech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients who require spinal fusion 2. Adult patients aged 20 or older 3. Patients who voluntarily agreed to participate in this study and signed the informed consent form, and who do not fall into any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume change of bony fusion mass in the CT | 1week, 6month, and 12month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree change of bony fusion mass in the X-ray | 1month, 3month, 6month, and 12month | 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. |
| Value of ROI(Region of interest) in the SPECT/CT | 3month | The osteoblastic activity levels at the surgical sites of the experiment and control groups shall be compared at three months post-operatively. |
| VAS Score change of Back pain questionnaire | screening, 6month and 12 month | 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. |
| ODI Score change of Back pain questionnaire | screening, 6month and 12 month | 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. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORYoung Hoon Kim, MD
The Catholic Univ. of Korea, Seoul St. Mary's Hospital
PRINCIPAL_INVESTIGATORYoung Yul Kim, MD
The Catholic Univ. of Korea, Daejeon St. Mary's Hospital
Outcome results
None listed