New bone putty shows promise in spinal surgery trial
NCT ID NCT02466048
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a material called SurgiFill™, which is used alongside a patient's own bone during spinal fusion surgery. The goal was to see if it helps the bones fuse better and safely. Twenty adults who needed spinal fusion took part, and doctors compared the fusion results on one side of the spine with SurgiFill™ versus the other side without it.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SurgiFill™ (bone grafting material)
- What this could lead to
- If successful, SurgiFill™ could improve bone fusion after spinal surgery, potentially reducing the need for additional bone grafts.
- What could go wrong
- This is a small, early-stage trial with only 20 participants, so results may not apply to everyone. The long-term safety and effectiveness are still uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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20 people
The number who actually took part.
- Start date
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Aug 2013
- Finished
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Nov 2016
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Catholic Univ. of Korea, Daejeon St. Mary's Hospital
Daejeon, Daejeon, 301723, South Korea
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The Catholic Univ. of Korea, Seoul St. Mary's Hospital
Seoul, Seoul, 137701, South Korea