New bone putty shows promise in spinal surgery trial

NCT ID NCT02466048

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

20 people

The number who actually took part.

Start date

Aug 2013

Finished

Nov 2016

Lead sponsor

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

20 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Fusion of spine (disease) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

  • 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