An observational study in Cervical Spondylosis, Cervical Radiculopathy and Cervical Myelopathy, sponsored by NuVasive. Enrolling by invitation at 3 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 anterior cervical spine surgery using the NuVasive anterior cervical plate (ACP) System 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 the NuVasive ACP System in patients who undergo anterior cervical spine surgery. 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 pathologic conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled in the study, subjects will undergo anterior cervical spine surgery using the NuVasive ACP System based on the surgeon's standard of care. At least 75 subjects will be enrolled and will be followed for 24 months after the surgery.
142 studies on the registry are indexed under Spondylosis; 42 are open to participants now.
This study's planned enrollment of 75 is below the median of 100 across 36 observational studies indexed under Spondylosis.
Browse Spondylosis 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:
The Evaluable Populations will include all subjects who:
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.
Have planned anterior cervical (C2 to C7) spine surgery using the NuVasive ACP System in conjunction with a NuVasive interbody implant or vertebral body replacement device (VBR), or a structural bone allograft spacer, for treatment of any of the following conditions:
Exclusion Criteria:
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 NuVasive ACP System
Rate of complications (i.e., safety) attributable to use of the NuVasive ACP System
Time frame: 24 months
Radiographic Success
Proportion of subjects with radiographic success at: 1. Latest time point available for patients undergoing surgery to treat advanced stage tumors 2. 24 months postoperative for subjects undergoing surgery to treat instabilities, traumatic spinal fractures, failed previous fusions, or degenerative disease
Time frame: 24 months
Clinical Outcome Success
Percentage of subjects meeting minimal clinically important difference (MCID) and/or substantial clinical benefit (SCB) thresholds for each PRO: neck and arm pain (measured by visual analog scale (VAS)), disability (measured by neck disability index (NDI)), and overall physical and mental health (measured by PROMIS-10)
Time frame: 24 months
Rate of Postoperative Dysphagia
Rate of postoperative dysphagia as measured by the Eating Assessment Tool (EAT-10)
Time frame: 24 months
Rate of complications attributable to the use of NuVasive instruments, implants, or technologies
Rate of complications attributable to the use of NuVasive instruments, implants, or technologies
Time frame: 24 months
Started May 2022 (actual). Primary completion is estimated for Sep 2026, 52 months after the start.
Of 18 observational studies under Spondylosis, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 74. This study's planned 52 months is above 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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