An observational study in Degenerative Disc Disease and Cervical Spinal Instability, sponsored by NuVasive. Enrolling by invitation at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by NuVasive (part of Globus Medical) · Observational
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).
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.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's planned enrollment of 150 is above the median of 119 across 170 observational studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →NuVasive is the lead sponsor of 38 studies on the registry; 8 are open to participants now.
First submitted before NuVasive became part of Globus Medical.
Counted across the registry records on this site, refreshed daily.
The Enrolled Population will include all subjects who meet the criteria for enrollment, specifically, those subjects who:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Using one of the following implants (NuVasive, Inc., San Diego, CA):
Exclusion Criteria:
Use of any bone graft that is not cleared by the applicable regulatory body for use within interbody implants. Examples of these include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Complications of Interbody Implants
Rate of complications (i.e., safety) attributable to the use of the interbody implants to be studied.
Time frame: 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.
Time frame: 24 months
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".
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.
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.
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.
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.
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).
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.
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).
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"
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
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.
Time frame: 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.
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2020 (actual). Primary completion is estimated for Dec 2025, 65 months after the start.
Of 80 observational studies under Intervertebral Disc Degeneration, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 84. This study's planned 65 months is close to that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Intervertebral Disc Degeneration →