New spinal implants under study for neck pain relief
NCT ID NCT04689854
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how safe and effective special spinal implants are for people with worn-out discs or unstable neck bones. About 150 adults who need neck surgery will receive these implants and be followed for 24 months. The goal is to see if the bones fuse properly and if patients feel better with less pain.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2020
- Expected to finish
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Dec 2025
An estimate. End dates often move.
- 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
The Enrolled Population will include all subjects who meet the criteria for enrollment, specifically, those subjects who: * Satisfied the inclusion and exclusion criteria * Signed the informed consent * Underwent the surgical procedure, as defined in this protocol Subjects not meeting any of these criteria will not be considered enrolled in the study, and therefore not included in any study population or analysis.
- Ages
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18 years and older
- 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.
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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 are ≥18 years of age at the time of consent 2. Have a planned spine surgery using interbody implants at one or more cervical levels (C2-T1) for degenerative disc disease and/or cervical spinal instability 3. Using one of the following implants (NuVasive, Inc., San Diego, CA): 1. Cohere Cervical 2. Modulus Cervical 4. With interbody fusion using autograft and/or allograft (i.e., cancellous and/or corticocancellous allograft bone) and NuVasive supplemental internal fixation cleared by the applicable regulatory body for use in the cervical spine 5. Able to undergo surgery based on physical exam, medical history, and surgeon judgment 6. Understands the conditions of enrollment, is willing to follow medical advice including postoperative activity restrictions per the surgeon's standard of care, and is willing to sign an informed consent form to participate in the study Exclusion Criteria: 1. Use of any bone graft that is not cleared by the applicable regulatory body for use within interbody implants. Examples of these include: 1. Bone morphogenic protein (BMP) (i.e., Infuse (Medtronic)) 2. Synthetic bone graft extenders (e.g., Formagraft (NuVasive), Mastergraft (Medtronic), Vitoss (Stryker), Actifuse (Baxter), nanOss (RTI Surgical), Fibergraft (Prosidyan/Depuy Synthes), and ChronOs (Depuy Synthes)) 3. Demineralized bone matrices (DBM) regulated as medical devices by the FDA (e.g., Grafton Putty/Gel (Medtronic), DBX (MTF/Depuy Synthes), Accell Evo3 (IsoTis), and Propel Putty/Gel (NuVasive)) 4. Peptide enhanced bone graft (e.g., iFactor (Cerapedics)) 2. Previous cervical fusion surgery at the level(s) to be treated (adjacent level surgery is acceptable; prior decompression is acceptable) 3. Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested) 4. Use of bone growth stimulators postoperatively 5. Active smoking within 6 weeks before surgery 6. Patient has known sensitivity to the materials implanted 7. Systemic or local infection (latent or active) or signs of local inflammation 8. Patient has inadequate bone stock or bone quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment 9. Patient is a prisoner 10. Patient is participating in another clinical study 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Columbia Orthopedic Group Research
Columbia, Missouri, 65201, United States
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Duke University
Durham, North Carolina, 27710, United States
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Hartford Healthcare Bone and Joint Institute
Hartford, Connecticut, 06106, United States
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Mass General Brigham
Somerville, Massachusetts, 02145, United States
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Orthopedic Specialty Institute
Orange, California, 92868, United States
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Summa Health
Akron, Ohio, 44320, United States
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University of Virginia
Charlottesville, Virginia, 22908, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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