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NuVasive® ACP System Study | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATION

NuVasive® ACP System Study

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

NCT05066711•NuVasive

View on ClinicalTrials.gov

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).

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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

Locations (3)

Duly Health and Care

Naperville, Illinois, United States

Columbia Orthopedic Group Research

Columbia, Missouri, United States

Atlantic Brain and Spine

Wilmington, North Carolina, United States

Key Dates

Start Date

May 22, 2022

Primary Completion Date

September 30, 2026

Completion Date

June 30, 2027

Last Updated

December 22, 2025

Enrollment

ESTIMATED participants

Conditions

Cervical SpondylosisCervical RadiculopathyCervical MyelopathyCervical Disc DiseaseCervical StenosisCervical Disc HerniationCervical Spine Disease

Investigation of the Effects of Interlaminar Epidural Steroid Injection on Upper Extremity Proprioception in Patients With Chronic Cervical Radiculopathy

NCT07307846

Cervical RadiculopathyCervical Radicular Pain+1 more

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RECRUITING

Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion

NCT06601634

Neck PainCervical Spondylosis+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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NuVasive® ACP System Study

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Interlaminar Epidural Steroid Injection on Upper Extremity Proprioception in Patients With Chronic Cervical Radiculopathy

Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion

Predictors of Response to Manual Physiotherapy Using Somatosensory Profiles in Patients With Cervicobrachial Pain

Study on the Treatment of C/S of Qi Stagnation and Blood-stasis Type by Moving Cupping with Bloodletting

Local Vibration in Cervical Radiculopathy

Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating Cervical Ossification of the Posterior Longitudinal Ligament