Clinical Trial to Evaluate the Efficacy and Safety of SurgiFill™ on Spinal Fusion -Comparison Between Autograft Mixed With SurgiFill™ and Autograft in Spinal Fusion-
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Volume change of bony fusion mass in the CT
研究概览
简要总结
This study was designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with spinal fusion.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who require spinal fusion
- •Adult patients aged 20 or older
- •Patients who voluntarily agreed to participate in this study and signed the informed consent form, and who do not fall into any of the
排除标准
- •Exclusion Criteria:
- •Patients or their family members with a history of an, or an ongoing, autoimmune disease
- •Patients with a history of anaphylactic response
- •Patients with hypersensitivity to grafting materials
- •Patients with hypersensitivity to pig protein
- •Patients with osteomyelitis in the surgery area
- •Patients who are pregnant, breastfeeding, or planning to become pregnant
- •Patients with other tumors or a non-curable disease
- •Patients with a history of radiation therapy or cancer treatment within two years (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)
- •Patients with diabetes (Those who maintain a normal blood sugar level and did not develop complications may receive the SurgiFill™ injection based on the investigator's judgment, but the doctor's confirmation is required.)
- •Patients with an infection that required hospitalization for antibiotics or the administration of antiseptic agents
- •Patients who have been undergoing adrenocortical hormone therapy (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)
- •Patients with liver, heart, or kidney disease (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment. Hypertension patients are allowed.)
- •Patients who had been infected with a virus (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)
- •Patients with chronic renal failure or an endocrine system disease (Those who show normal or insignificant test results may be enrolled in this study and receive the SurgiFill™ injection based on the investigator's judgment.)
- •Patients who are considered inappropriate for participation in this study due to their condition (e.g., a mental illness) based on the investigator's judgment
- •Patients who had participated in another clinical trial (limited to those who participated in other studies on fracture within the last six months.)
研究组 & 干预措施
SurgiFill™ on Spinal Fusion
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.
干预措施: Spinal Fusion (Procedure)
SurgiFill™ on Spinal Fusion
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.
干预措施: SurgiFill™ (Device)
Autograft on Spinal Fusion
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.
干预措施: Spinal Fusion (Procedure)
结局指标
主要结局
Volume change of bony fusion mass in the CT
时间窗: 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.
次要结局
- Degree change of bony fusion mass in the X-ray(1month, 3month, 6month, and 12month)
- VAS Score change of Back pain questionnaire(screening, 6month and 12 month)
- Value of ROI(Region of interest) in the SPECT/CT(3month)
- ODI Score change of Back pain questionnaire(screening, 6month and 12 month)