NCT02466048

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2013

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

2.2 years

First QC Date

June 1, 2015

Last Update Submit

June 4, 2015

Conditions

Spinal Fusion AcquiredFusion of Spine (Disease)

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™DEVICE

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

SurgiFill™ on Spinal Fusion

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:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Daejeon, Daejeon, 301723, South Korea

RECRUITING

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

Seoul, Seoul, 137701, South Korea

ACTIVE NOT RECRUITING

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 TherapyTherapeuticsTransplantation

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

Central Study Contacts

Hyun Jo Kim, Bachelor

CONTACT

822-460-3237angel@swcell.com

Study Design

Study Type
interventional
Phase
phase 4
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 1, 2013

Primary Completion

October 1, 2015

Study Completion

January 1, 2016

Last Updated

June 9, 2015

Record last verified: 2015-06

Locations

KR(2)