Trials Sponsors Conditions Drugs Pricing

Conditions

Fusion of Spine (Disease)Spinal Fusion Acquired

Keywords

spinal fusionbone graftcollagen

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

Degree change of bony fusion mass in the X-ray
1month, 3month, 6month, and 12month
Value of ROI(Region of interest) in the SPECT/CT
3month
VAS Score change of Back pain questionnaire
screening, 6month and 12 month
ODI Score change of Back pain questionnaire
screening, 6month and 12 month

Other Outcomes (1)

Number of abnormal blood test result of participants with adverse events as a measure of safety
up to 12month

Study Arms (2)

SurgiFill™ on Spinal Fusion

EXPERIMENTAL

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.

Procedure: Spinal FusionDevice: SurgiFill™

Autograft on Spinal Fusion

ACTIVE COMPARATOR

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.

Procedure: Spinal Fusion

Interventions

Spinal FusionProcedure

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.

Also known as: Spinal Fusion, spondylodesis, spondylosyndesis, bone graft

Autograft on Spinal FusionSurgiFill™ on Spinal Fusion

SurgiFill™

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients who require spinal fusion
Adult patients aged 20 or older

You may not qualify if:

Sponsors & Collaborators

Cellontech Co., Ltd.
Industrylead

Study Sites (2)

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

Daejeon, Daejeon, 301723, South Korea

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

Seoul, Seoul, 137701, South Korea

MeSH Terms

Conditions

Disease

Interventions

Spinal FusionBone Transplantation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ArthrodesisOrthopedic ProceduresSurgical Procedures, OperativeTissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeutics

Study Officials

Young Hoon Kim, MD
The Catholic Univ. of Korea, Seoul St. Mary's Hospital
PRINCIPAL INVESTIGATOR
Young Yul Kim, MD
The Catholic Univ. of Korea, Daejeon St. Mary's Hospital
PRINCIPAL INVESTIGATOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 1, 2015

First Posted

June 9, 2015

Study Start

August 2013

Date type not reported

This date has not been verified as actual or estimated.

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
+1 more criteria

Efficacy and Safety of SurgiFill™ on Spinal Fusion

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (1)

Study Arms (2)

SurgiFill™ on Spinal Fusion

Autograft on Spinal Fusion

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (1)

Study Arms (2)

SurgiFill™ on Spinal Fusion

Autograft on Spinal Fusion

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations