Efficacy and Safety of SurgiFill™ on Spinal Fusion

Sewon Cellontech

Status and phase: Unknown; Phase 4

Conditions: Spinal Fusion Acquired; Fusion of Spine (Disease)

Treatments: Procedure: Spinal Fusion; Device: SurgiFill™

Study type: Interventional

Funder types: Industry

Identifiers

NCT02466048

02SGF

Details and patient eligibility

About

This study was designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with spinal fusion.

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

SurgiFill™ on Spinal Fusion

Experimental group

Description:

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.

Treatment:

Procedure: Spinal Fusion

Device: SurgiFill™

Autograft on Spinal Fusion

Active Comparator group

Description:

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.

Treatment:

Procedure: Spinal Fusion