New neck plate aims to stabilize spine after surgery

NCT ID NCT05066711

Disease control Sponsor: NuVasive Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a metal plate (the NuVasive ACP system) used during neck spine surgery to treat conditions like disc disease, stenosis, or fractures. About 75 adults will receive the plate and be followed for up to 24 months to see how safe it is and how well it helps with pain and function. The goal is to see if the plate helps the spine heal properly without major complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: NuVasive anterior cervical plate (ACP) system
What this could lead to: If successful, this could provide a safe and effective option for stabilizing the cervical spine after surgery, potentially improving pain and function for patients with neck spine conditions.
What could go wrong: This is a relatively small study (75 people) and is not randomized or blinded, so results may not apply to everyone. As with any spine surgery, risks include infection, nerve damage, or the plate not fusing properly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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, 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.

Ages: 18 years and older
Sex: Anyone

Show the full entry requirements

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 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: 1. degenerative disc disease, as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies 2. trauma (including fractures) 3. tumors involving the cervical spine 4. cervical spinal deformity (kyphosis, lordosis, or scoliosis) 5. failed previous cervical fusion(s) (e.g., pseudoarthrosis) 6. cervical spondylolisthesis 7. cervical spinal stenosis 3. Able to undergo surgery based on physical exam, medical history, and surgeon judgment 4. Understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study Exclusion Criteria: 1. Procedures performed with interbody implants with integrated vertebral body screw(s) 2. Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested) 3. Use of bone growth stimulators postoperatively 4. Active smoking within 6 weeks of surgery 5. Patient has known sensitivity to materials implanted 6. Systemic or local infection (latent or active) or signs of local inflammation 7. Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment 8. Pregnant, or plans to become pregnant 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.

cervical disk degenerative disorder lumbar disk degenerative disorder radiculopathy spinal injury spinal stenosis spondylolisthesis spondylosis spondylosis, cervical

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical disc disease Cervical disc herniation Cervical myelopathy Cervical radiculopathy Cervical spine disease Cervical spondylosis Cervical stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

3 sites. The list below names each one and where it is.
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.

New neck plate aims to stabilize spine after surgery

What the study statuses mean