Cervical SpondylosisNCT05066711
NuVasive® ACP System Study
An observational study of Cervical Spondylosis and Cervical Radiculopathy, run by NuVasive at 3 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Spondylosis, Cervical Radiculopathy, Cervical Myelopathy
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 May 2022to 30 Jun 2027
- 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
- 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, and * 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. The Evaluable Populations will include all subjects who: * Were included in the Enrolled Populations, * Completed the study, and * Had no major protocol deviations. If there are no major protocol deviations and all subjects complete the study, then an Evaluable Population will not be used.
Who may be able to join
- Patients who are ≥18 years of age at the time of consent
- 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:
- degenerative disc disease, as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
- trauma (including fractures)
- tumors involving the cervical spine
- cervical spinal deformity (kyphosis, lordosis, or scoliosis)
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- failed previous cervical fusion(s) (e.g., pseudoarthrosis)
- cervical spondylolisthesis
- cervical spinal stenosis
- Able to undergo surgery based on physical exam, medical history, and surgeon judgment
- Understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study
Who cannot join
- Procedures performed with interbody implants with integrated vertebral body screw(s)
- 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 of surgery
- Patient has known sensitivity to materials implanted
- Systemic or local infection (latent or active) or signs of local inflammation
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- Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment
- Pregnant, or plans to become pregnant
- Patient is a prisoner
- Patient is participating in another clinical study that would confound study data
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Columbia Orthopedic Group Research
Columbia, Missouri, 65201
Duly Health and Care
Naperville, Illinois, 60540
Atlantic Brain and Spine
Wilmington, North Carolina, 28401
About this study
Official title: A Prospective, Multicenter Study Evaluating the Safety and Performance of the NuVasive® ACP System for the Treatment of Patients With Pathologic Conditions of the Cervical Spine
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).
Read the detailed description
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.
- Conditions
- Cervical Spondylosis, Cervical Radiculopathy, Cervical Myelopathy, Cervical Disc Disease, Cervical Stenosis, Cervical Disc Herniation
- Keywords
- Spine surgery
- Medical subject headings
- Spondylosis, Radiculopathy
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 |
|---|---|---|
| ACP System | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications NuVasive ACP System
Rate of complications (i.e., safety) attributable to use of the NuVasive ACP System
Measured: 24 months
Radiographic Success
Proportion of subjects with radiographic success at:
- Latest time point available for patients undergoing surgery to treat advanced stage tumors
- 24 months postoperative for subjects undergoing surgery to treat instabilities, traumatic spinal fractures, failed previous fusions, or degenerative disease
Measured: 24 months
Secondary outcomes (3)
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)
Measured: 24 months
Rate of Postoperative Dysphagia
Rate of postoperative dysphagia as measured by the Eating Assessment Tool (EAT-10)
Measured: 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
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 posted4 Oct 2021
- Study start22 May 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpondylosisStudies 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
- 75 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 Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066711
- Sponsor's protocol ID
- NUVA.ACP0721
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2021
- Last updated
- 22 Dec 2025
- Results posted
- 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 the NuVasive® ACP System for the Treatment of Patients With Pathologic Conditions of the Cervical Spine
- ClinicalTrials.gov ID
- NCT05066711
- Acronym / sponsor ID
- NUVA.ACP0721
- Conditions
- Cervical Spondylosis, Cervical Radiculopathy, Cervical Myelopathy, Cervical Disc Disease, Cervical Stenosis, Cervical Disc Herniation
- Keywords
- Spine surgery
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- 22 May 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 4 Oct 2021 (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 anterior cervical spine surgery using the NuVasive anterior cervical plate (ACP) System 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACP System | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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, and * 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. The Evaluable Populations will include all subjects who: * Were included in the Enrolled Populations, * Completed the study, and * Had no major protocol deviations. If there are no major protocol deviations and all subjects complete the study, then an Evaluable Population will not be used.
Key inclusion criteria (11 listed)
- Patients who are ≥18 years of age at the time of consent
- 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:
- Able to undergo surgery based on physical exam, medical history, and surgeon judgment
- Understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study
Key exclusion criteria (10 listed)
- Procedures performed with interbody implants with integrated vertebral body screw(s)
- 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 of surgery
- Patient has known sensitivity to materials implanted
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 NuVasive ACP System
Time frame: 24 months
Rate of complications (i.e., safety) attributable to use of the NuVasive ACP System
Radiographic Success
Time frame: 24 months
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
3 secondary outcomes
Clinical Outcome Success
Time frame: 24 months
Rate of Postoperative Dysphagia
Time frame: 24 months
Rate of complications attributable to the use of 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.
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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 Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spondylosis and Cervical Radiculopathy, run by NuVasive at 3 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 11 inclusion and 10 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 3 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 NuVasive ACP System (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.