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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SurgiFill™ on Spinal Fusion | Experimental | 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. |
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| Autograft on Spinal Fusion | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Fusion | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1week, 6month, and 12month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young Hoon Kim, MD | The Catholic Univ. of Korea, Seoul St. Mary's Hospital | Principal Investigator |
| Young Yul Kim, MD | The Catholic Univ. of Korea, Daejeon St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic Univ. of Korea, Daejeon St. Mary's Hospital | Daejeon | Daejeon | 301723 | South Korea | ||
| The Catholic Univ. of Korea, Seoul St. Mary's Hospital |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013123 | Spinal Fusion |
| D016025 | Bone Transplantation |
| ID | Term |
|---|---|
| D001174 | Arthrodesis |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D016378 | Tissue Transplantation |
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| SurgiFill™ | Device | SurgiFill™ is a gel-type high-purity ateolcollagen for bone grafting. SurgiFill™ is used with autogenous iliac graft for dorsolateral spinal fusion. |
|
| 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. | 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. | 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. | screening, 6month and 12 month |
| up to 12month |
| Seoul |
| Seoul |
| 137701 |
| South Korea |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |