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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Cervical Radiculopathy; Cervical Disc Disease; Cervical Spine Disease; Cervical Myelopathy; Cervical Spondylosis; Cervical Disc Herniation; Cervical Stenosis

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 Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Naperville, Illinois, United States, 60540
      • Duly Health and Care
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Columbia Orthopedic Group Research
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Atlantic Brain and Spine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ACP System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications NuVasive ACP System	Rate of complications (i.e., safety) attributable to use of the NuVasive ACP System	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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	24 months
Rate of Postoperative Dysphagia	Rate of postoperative dysphagia as measured by the Eating Assessment Tool (EAT-10)	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	24 months

Collaborators and Investigators

• Sponsor: NuVasive
• Investigators: Study Director: Kyle Malone, MS, Globus Medical Inc

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Spine surgery
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Radiculopathy; Spondylosis
• Other Study ID Numbers: NUVA.ACP0721