New bone graft shows promise for neck surgery patients
NCT ID NCT02814825
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how well ViviGen, a bone graft made from donated human bone cells, helps fuse neck bones in people having 2- or 3-level neck surgery. 100 patients were followed to see if their bones fused and how their pain and function improved. The goal was to gather real-world data on this already-approved product.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ViviGen cellular bone matrix (a bone graft material made from donated human bone cells and tissue)
- What this could lead to
- If successful, this could confirm that ViviGen helps neck bones fuse together better after surgery, potentially improving recovery and reducing pain.
- What could go wrong
- This is a small, single-arm study with no comparison group, so results may not prove ViviGen is better than other bone graft materials. Fusion success also depends on many factors beyond the graft.
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.
- Participants
-
100 people
The number who actually took part.
- Started
-
Jun 2016
- Finished
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Apr 2021
- 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.
Who is studied
Male or female patients with cervical spondylosis, degenerative disc disease (DDD), or herniated nucleus pulposus (HNP) who are to receive cervical spine surgery with anterior column support at two or three contiguous levels (C2-C7)
- Ages
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21 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: Candidates who satisfy ALL of the following inclusion criteria and consent to participate in the study may be considered eligible for enrollment: 1. Diagnosed by the investigator with at least one (1) of the following: * Symptomatic cervical spondylosis; * Degenerative disc disease (DDD), defined as discogenic pain with degeneration of the disc confirmed by history and imaging studies; * Herniated nucleus pulposus (HNP) 2. Subjects who are candidates and have already elected to undergo contiguous two or three-level ACDF surgery between C2-C7 of the cervical spine 3. Skeletally mature adults between 21 and 75 years of age 4. Subjects, who, in the opinion of the Investigator, are able to understand the purpose of the study and are willing to return for all the required post-operative standard of care follow-up visits and have their data collected. Exclusion Criteria: Candidates who meet ANY of the following exclusion criteria are not considered eligible for study participation: 1. Posterior instrumentation necessary at same levels being treated 2. Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine 3. Instability associated with cervical spine trauma 4. Acute or chronic systemic or localized spinal infections 5. Previous deep anterior cervical surgeries such as thyroid, carotid, or high thoracic surgery (T5 and above) 6. History of previous cervical fusion surgery at greater than one level 7. Previous pseudoarthrosis at any level of the cervical spine 8. Nursing mothers or women who are pregnant or plan to become pregnant during the time of the study 9. Severe osteoporosis (per the Investigator's diagnosis or per a T-score greater than or equal to 2.5 SD below the mean for a young, healthy adult) that may prevent adequate fixation of screws and thus preclude the use of a cervical plate system 10. Subjects who have a known or suspected allergy to any of the following antibiotics and/or reagents: Gentamicin Sulfate, Meropenem, Vancomycin, Dimethyl Sulfoxide (DMSO), and Human Serum Albumin (HSA) 11. Immune compromised subjects 12. Pre-existing neurological abnormalities other than deficits produced by the spinal fusion (e.g. MS, Parkinson's, CVA, diabetic neuropathy, peripheral neuropathy) 13. Conditions that could preclude the possibility of fusion in the Investigator's opinion (e.g. cancer, kidney dialysis, smoking, uncontrolled diabetes, osteopenia) 14. History of pre-operative dysphagia 15. Symptomatic shoulder pathologies under active treatment 16. Known sensitivity to device materials 17. Subjects who, in the opinion of the Investigator, have any other existing condition that would compromise their participation and follow-up in this clinical study Intraoperative exclusion criteria: 18. Intraoperative decision by the surgeon to use implants not compatible or cleared for use with ViviGen 19. Intraoperative decision by the surgeon to use other bone grafts substitutes such as DBM or rhBMP
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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