Efficacy and Safety of SurgiFill™ on Spinal Fusion

NCT ID: NCT02466048

Last Updated: 2015-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-01-31

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).

Conditions

Spinal Fusion Acquired; Fusion of Spine (Disease)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Spinal Fusion

Intervention Type: 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.

SurgiFill™

Intervention Type: DEVICE

SurgiFill™ is a gel-type high-purity ateolcollagen for bone grafting. SurgiFill™ is used with autogenous iliac graft for dorsolateral spinal fusion.

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.

Group Type: ACTIVE_COMPARATOR

Spinal Fusion

Intervention Type: 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.

Interventions

Spinal 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.

Intervention Type: PROCEDURE

SurgiFill™

SurgiFill™ is a gel-type high-purity ateolcollagen for bone grafting. SurgiFill™ is used with autogenous iliac graft for dorsolateral spinal fusion.

Intervention Type: DEVICE

Other Intervention Names

Spinal Fusion, spondylodesis, spondylosyndesis, bone graft

Eligibility Criteria

Inclusion Criteria

1. Patients who require spinal fusion

2. Adult patients aged 20 or older

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.)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sewon Cellontech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Young Hoon Kim, MD

Role: PRINCIPAL_INVESTIGATOR

The Catholic Univ. of Korea, Seoul St. Mary's Hospital

Young Yul Kim, MD

Role: PRINCIPAL_INVESTIGATOR

The Catholic Univ. of Korea, Daejeon St. Mary's Hospital

Locations

The Catholic Univ. of Korea, Daejeon St. Mary's Hospital

Daejeon, Daejeon, South Korea

Site Status: RECRUITING

The Catholic Univ. of Korea, Seoul St. Mary's Hospital

Seoul, Seoul, South Korea

Site Status: ACTIVE_NOT_RECRUITING

Countries

South Korea

Central Contacts

Hyun Jo Kim, Bachelor

Role: CONTACT

angel@swcell.com

822-460-3237

Other Identifiers

02SGF

Identifier Type: -

Identifier Source: org_study_id