Clinical trial NCT02466048: Efficacy and Safety of SurgiFill™ on Spinal Fusion
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-
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spinal Fusion Acquired
Fusion of Spine (Disease)
Keywords: spinal fusion
bone graft
collagen
Lead sponsor: Sewon Cellontech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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 exclusion criteria

Exclusion Criteria:

1. Patients or their family members with a history of an, or an ongoing, autoimmune disease
2. Patients with a history of anaphylactic response
3. Patients with hypersensitivity to grafting materials
4. Patients with hypersensitivity to pig protein
5. Patients with osteomyelitis in the surgery area
6. Patients who are pregnant, breastfeeding, or planning to become pregnant
7. Patients with other tumors or a non-curable disease
8. 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.)
9. 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.)
10. Patients with an infection that required hospitalization for antibiotics or the administration of antiseptic agents
11. 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.)
12. 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.)
13. 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.)
14. 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.)
15. 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
16. Patients who had participated in another clinical trial (limited to those who participated in other studies on fracture within the last six months.)

Primary outcomes:
measure: Volume change of bony fusion mass in the CT
timeFrame: 1week, 6month, and 12month
Secondary outcomes:
measure: Degree change of bony fusion mass in the X-ray
timeFrame: 1month, 3month, 6month, and 12month
measure: Value of ROI(Region of interest) in the SPECT/CT
timeFrame: 3month
measure: VAS Score change of Back pain questionnaire
timeFrame: screening, 6month and 12 month
measure: ODI Score change of Back pain questionnaire
timeFrame: screening, 6month and 12 month
Other outcomes:
measure: Number of abnormal blood test result of participants with adverse events as a measure of safety
timeFrame: up to 12month
Locations:
city: Daejeon
country: Korea, Republic of
facility: The Catholic Univ. of Korea, Daejeon St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea, Seoul St. Mary's Hospital
Study officials:
affiliation: The Catholic Univ. of Korea, Seoul St. Mary's Hospital
name: Young Hoon Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic Univ. of Korea, Daejeon St. Mary's Hospital
name: Young Yul Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: