New bone graft shows promise in neck fusion surgery
NCT ID NCT00942045
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at a product called Osteocel Plus used during neck fusion surgery for people with degenerative disc disease. The goal was to see how well the bones fused together and how safe the product was. 182 adults were followed for 24 months after surgery. The results were compared to older data from other bone graft materials.
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
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182 people
The number who actually took part.
- Start date
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Feb 2009
- Finished
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Oct 2012
- 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.
Who is studied
Existing clinic patients
- Ages
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18 to 70 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: 1. Persistent neck and/or arm pain unresponsive to conservative treatment for at least 6 weeks, unless clinically indicated sooner 2. Indicated for anterior fusion at one or two contiguous cervical levels (C3 to T1) 3. Objective evidence of primary diagnosis must be confirmed by appropriate imaging studies 4. 18-70 years of age at the date of written informed consent 5. Able to undergo surgery based on physical exam, medical history and surgeon judgment 6. Expected to survive at least 2 years beyond surgery 7. Willing and able to return for post-treatment exams according to the follow-up called for in the protocol 8. Signed and dated Informed Consent Form Exclusion Criteria: 1. Patient has a mental or physical condition that would limit the ability to comply with study requirements 2. Cervical spine abnormality requiring treatment at more than two levels 3. Systemic or local infection; active or latent 4. Previous failed fusion at the operative level 5. Diseases that significantly inhibit bone healing (osteoporosis, metabolic bone disease, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease) 6. Undergoing chemotherapy or radiation treatment, or chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids) 7. Pregnant, or plans to become pregnant during the study 8. Subject is a prisoner 9. Involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contended) 10. A significant general illness (e.g., HIV, active metastatic cancer of any type) is present; subject is immunocompromised or is being treated with immunosuppressive agents that decrease the probability of survival to the two-year endpoint of the study 11. Participating in another clinical study at any time during the study participation that would confound study data
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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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Buffalo Spine Surgery, Kenmore Mercy
Lockport, New York, 14094, United States
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Columbia Orthopaedic Group, Boone Hospital Center
Columbia, Missouri, 65201, United States
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Duke University Medical Center
Durham, North Carolina, 27708, United States
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Hinsdale Orthopaedic Associates, Provena Saint Joseph Medical Center
Joliet, Illinois, 60435, United States
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Indiana Center for NeuroSurgery, Indiana Surgery Center East
Indianopolis, Indiana, 46219, United States
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NWREI (for Ortho Montana)
Billings, Montana, 59101, United States
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Pinnacle Orthopaedics, Wellstone Kennestone Hospital
Marietta, Georgia, 30060, United States
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Shiley Center for Orthopaedic, Scripps Green Hospital
La Jolla, California, 92037, United States
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Spine Team Texas, Texas Health Harris Methodist Hospital Southlake
Southlake, Texas, 76092, United States
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Stanford University
Redwood City, California, 94063, United States
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Swedish Medical Center
Seattle, Washington, 98122, United States
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The Center for Advanced Orthopaedics, Adena Bone and Joint Center
Chillicothe, Ohio, 45601, United States
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The Spine Institute, St. John's Health Center
Santa Monica, California, 90404, United States
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UCSD Department of Orthpaedic Surgery, UCSD Medical Center
San Diego, California, 92103, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19106, United States
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University of South Florida Department of Neurosurgery, Tampa General Hospital
Tampa, Florida, 33606, United States
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Winchester Medical Center
Winchester, Virginia, 22601, United States