Spinal Fusion AcquiredNCT02466048
Efficacy and Safety of SurgiFill™ on Spinal Fusion
A study testing Spinal Fusion and SurgiFill™ in people with Spinal Fusion Acquired and Fusion of Spine (Disease), run by Cellontech Co., Ltd. at 2 sites in South Korea.
Trial summary
This study was designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with spinal fusion. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Fusion Acquired, Fusion of Spine (Disease)
- What is being tested?
- Spinal Fusion and SurgiFill™
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Aug 2013to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who require spinal fusion
- Adult patients aged 20 or older
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
- Patients who had participated in another clinical trial (limited to those who participated in other studies on fracture within the last six months.)
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
The Catholic Univ. of Korea, Daejeon St. Mary's Hospital
Daejeon, Daejeon, 301723
The Catholic Univ. of Korea, Seoul St. Mary's Hospital
Seoul, Seoul, 137701
About this study
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-
This study was designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with spinal fusion.
Read the 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)
- Being tested
- Spinal Fusion, SurgiFill™
- Keywords
- spinal fusion, bone graft, collagen
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal FusionProcedure or surgery
Also called Spinal Fusion, spondylodesis, spondylosyndesis, bone graft
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™Device
SurgiFill™ is a gel-type high-purity ateolcollagen for bone grafting. SurgiFill™ is used with autogenous iliac graft for dorsolateral spinal fusion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Spinal Fusion; Device: 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. Receives: Procedure: Spinal Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1week, 6month, and 12month
Secondary outcomes (4)
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.
Measured: 1month, 3month, 6month, and 12month
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.
Measured: 3month
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.
Measured: screening, 6month and 12 month
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.
Measured: screening, 6month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startAug 2013
- Primary completionFeb 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Fusion AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellontech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young Hoon Kim, MD, Principal investigator, The Catholic Univ. of Korea, Seoul St. Mary's HospitalYoung Yul Kim, MD, Principal investigator, The Catholic Univ. of Korea, Daejeon St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466048
- Sponsor's protocol ID
- 02SGF
- Status last verified
- Nov 2016
- First submitted
- 1 Jun 2015
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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-
- ClinicalTrials.gov ID
- NCT02466048
- Acronym / sponsor ID
- 02SGF
- Conditions
- Spinal Fusion Acquired, Fusion of Spine (Disease)
- Keywords
- spinal fusion, bone graft, collagen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cellontech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SurgiFill™ on Spinal Fusion | Experimental | Procedure: Spinal Fusion, Device: SurgiFill™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. |
| Autograft on Spinal Fusion | Active comparator | Procedure: Spinal FusionIn one side of one patient, autogenous bones and SurgiFill™ will be grafted; and in the other side, only the autogenous bones will be grafted. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who require spinal fusion
- Adult patients aged 20 or older
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal FusionAlso: Spinal Fusion, spondylodesis, spondylosyndesis, bone graftSpinal 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. | Procedure or surgery | Autograft on Spinal Fusion, SurgiFill™ on Spinal Fusion |
| SurgiFill™SurgiFill™ is a gel-type high-purity ateolcollagen for bone grafting. SurgiFill™ is used with autogenous iliac graft for dorsolateral spinal fusion. | Device | SurgiFill™ on Spinal Fusion |
Primary outcome
Volume change of bony fusion mass in the CT
Time frame: 1week, 6month, and 12month
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.
4 secondary outcomes
Degree change of bony fusion mass in the X-ray
Time frame: 1month, 3month, 6month, and 12month
Value of ROI(Region of interest) in the SPECT/CT
Time frame: 3month
VAS Score change of Back pain questionnaire
Time frame: screening, 6month and 12 month
ODI Score change of Back pain questionnaire
Time frame: screening, 6month and 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
Related trials for Spinal Fusion Acquired
Not yet recruiting
Preoperative Risk Evaluation and Per ERAS Intervention in the Chinese Elderly Patients Underwent Spinal Fusion Surgery
Degenerative Spinal Disease, Elderly Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Hoon Kim, MD principal investigator
The Catholic Univ. of Korea, Seoul St. Mary's Hospital
Young Yul Kim, MD principal investigator
The Catholic Univ. of Korea, Daejeon St. Mary's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Fusion and SurgiFill™ in people with Spinal Fusion Acquired and Fusion of Spine (Disease), run by Cellontech Co., Ltd. at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume change of bony fusion mass in the CT (time frame: 1week, 6month, and 12month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.