Degenerative Disc DiseaseNCT04689854
Cervical Interbody Implant Study
An observational study of Degenerative Disc Disease and Cervical Spinal Instability, run by NuVasive at 7 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and performance of cervical spine surgery using interbody implants as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Cervical Spinal Instability
- How many people
- 150 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 Jul 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patients who are ≥18 years of age at the time of consent
- 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
- Using one of the following implants (NuVasive, Inc., San Diego, CA):
- Cohere Cervical
- Modulus Cervical
- 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
- Able to undergo surgery based on physical exam, medical history, and surgeon judgment
- 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
Who cannot join
- Use of any bone graft that is not cleared by the applicable regulatory body for use within interbody implants. Examples of these include:
- Bone morphogenic protein (BMP) (i.e., Infuse (Medtronic))
- 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))
- 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))
- Peptide enhanced bone graft (e.g., iFactor (Cerapedics))
- Previous cervical fusion surgery at the level(s) to be treated (adjacent level surgery is acceptable; prior decompression is acceptable)
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- Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
- Use of bone growth stimulators postoperatively
- Active smoking within 6 weeks before surgery
- Patient has known sensitivity to the materials implanted
- Systemic or local infection (latent or active) or signs of local inflammation
- Patient has inadequate bone stock or bone quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment
- Patient is a prisoner
- Patient is participating in another clinical study that would confound study data
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Summa Health
Akron, Ohio, 44320
University of Virginia
Charlottesville, Virginia, 22908
Columbia Orthopedic Group Research
Columbia, Missouri, 65201
Duke University
Durham, North Carolina, 27710
Hartford Healthcare Bone and Joint Institute
Hartford, Connecticut, 06106
Orthopedic Specialty Institute
Orange, California, 92868
Mass General Brigham
Somerville, Massachusetts, 02145
About this study
Official title: A Prospective, Multicenter Study Evaluating the Safety and Performance of Interbody Implants for the Treatment of Patients With Degenerative Conditions of the Cervical Spine
The primary objective of this study is to evaluate the safety and performance of cervical spine surgery using interbody implants as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).
Read the detailed description
This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of select interbody implant devices in patients who undergo interbody fusion surgery of the cervical spine. Consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with degenerative conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled into the study, subjects will undergo interbody fusion surgery using one of the NuVasive interbody implant groups based on the surgeon's standard of care. At least 150 subjects (a minimum of 75 patients in each implant group) will be enrolled and will be followed for 24 months after the surgery.
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohere Cervical | Not described | |
| Modulus Cervical | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications of Interbody Implants
Rate of complications (i.e., safety) attributable to the use of the interbody implants to be studied.
Measured: 24 months
Radiographic Fusion Success
The proportion of subjects with apparent radiographic fusion (i.e., performance) of the index surgical level(s) at 24 months postoperative.
Measured: 24 months
Secondary outcomes (7)
Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for neck/arm pain measured by visual analog scale (VAS).
Neck and arm pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet MCID (2.5 points and 2.5 points respectively) where 0 is "No Pain" and 10 is "Unbearable Pain".
Measured: 24 months
Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the neck disability index.
Disability measured by the neck disability index (NDI) will be assessed to determine the percentage of subjects who meet MCID (7.5 points) where a higher score on the NDI indicates a more severe disability.
Measured: 24 months
Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline measured by overall physical and mental health from PROMIS-10.
Overall physical and mental health measured by PROMIS-10 will be assessed to determine the percentage of subjects who meet MCID (5 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.
Measured: 24 months
Percentage of subjects meeting Substantial clinical benefit (SCB) as compared to baseline for disability measured by the neck disability index (NDI).
Disability measured by the neck disability index (NDI) will be assessed to determine the percentage of subjects who meet SCB (9.5 points) where a higher score on the NDI indicates a more severe disability.
Measured: 24 months
Percentage of subject meeting Substantial Clinical Benefit (SCB) as compared to baseline for neck/arm pain measured by visual analog scale (VAS).
Neck and arm pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet SCB (3.5 points) where 0 is "No Pain" and 10 is "Unbearable Pain"
Measured: 24 months
Percentage of subjects meeting Substantial Clinical Benefit (SCB) as compared to baseline for measure by overall physical and mental health from PROMIS-10
Overall physical and mental health measured by PROMIS-10 will be assess to determine the percentage of subjects how meet SCB (6.8 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.
Measured: 24 months
Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies.
Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start7 Jul 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyle Malone, MS, Study director, Globus Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689854
- Sponsor's protocol ID
- NUVA.CIB0420
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2020
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study Evaluating the Safety and Performance of Interbody Implants for the Treatment of Patients With Degenerative Conditions of the Cervical Spine
- ClinicalTrials.gov ID
- NCT04689854
- Acronym / sponsor ID
- NUVA.CIB0420
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and performance of cervical spine surgery using interbody implants as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).
Detailed description
This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of select interbody implant devices in patients who undergo interbody fusion surgery of the cervical spine. Consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with degenerative conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled into the study, subjects will undergo interbody fusion surgery using one of the NuVasive interbody implant groups based on the surgeon's standard of care. At least 150 subjects (a minimum of 75 patients in each implant group) will be enrolled and will be followed for 24 months after the surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohere Cervical | – | – |
| Modulus Cervical | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- Patients who are ≥18 years of age at the time of consent
- 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
- Using one of the following implants (NuVasive, Inc., San Diego, CA):
- 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
- Able to undergo surgery based on physical exam, medical history, and surgeon judgment
Key exclusion criteria (14 listed)
- Use of any bone graft that is not cleared by the applicable regulatory body for use within interbody implants. Examples of these include:
- Previous cervical fusion surgery at the level(s) to be treated (adjacent level surgery is acceptable; prior decompression is acceptable)
- Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
- Use of bone growth stimulators postoperatively
- Active smoking within 6 weeks before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complications of Interbody Implants
Time frame: 24 months
Rate of complications (i.e., safety) attributable to the use of the interbody implants to be studied.
Radiographic Fusion Success
Time frame: 24 months
The proportion of subjects with apparent radiographic fusion (i.e., performance) of the index surgical level(s) at 24 months postoperative.
7 secondary outcomes
Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for neck/arm pain measured by visual analog scale (VAS).
Time frame: 24 months
Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the neck disability index.
Time frame: 24 months
Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline measured by overall physical and mental health from PROMIS-10.
Time frame: 24 months
Percentage of subjects meeting Substantial clinical benefit (SCB) as compared to baseline for disability measured by the neck disability index (NDI).
Time frame: 24 months
Percentage of subject meeting Substantial Clinical Benefit (SCB) as compared to baseline for neck/arm pain measured by visual analog scale (VAS).
Time frame: 24 months
Percentage of subjects meeting Substantial Clinical Benefit (SCB) as compared to baseline for measure by overall physical and mental health from PROMIS-10
Time frame: 24 months
Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies.
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyle Malone, MS study director
Globus Medical
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease and Cervical Spinal Instability, run by NuVasive at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications of Interbody Implants (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.