Efficacy and Safety of SurgiFill™ on Spinal Fusion

Fusion of Spine (Disease) Clinical Trial

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-

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02466048
• Other study ID #: 02SGF
• Status: Recruiting
• Phase: Phase 4
• First received: June 1, 2015
• Last updated: June 4, 2015
• Start date: August 2013
• Est. completion date: January 2016

Study information

• Verified date: June 2015
• Source: Sewon Cellontech Co., Ltd.
• Contact: Hyun Jo Kim, Bachelor
• Phone: 822-460-3237
• Email: angel[@]swcell.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug SafetyKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fusion of Spine (Disease)
• Spinal Fusion Acquired

Intervention

Procedure:
• 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.

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

Locations

Country	Name	City	State
Korea, Republic of	The Catholic Univ. of Korea, Daejeon St. Mary's Hospital	Daejeon
Korea, Republic of	The Catholic Univ. of Korea, Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sewon Cellontech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	up to 12month	Yes
Primary	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	No
Secondary	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.	1month, 3month, 6month, and 12month	No
Secondary	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	No
Secondary	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	No
Secondary	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	No