NuVasive® ACP System Study

NCT05066711 | Enrolling By Invitation

• 1 other identifier: NUVA.ACP0721
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Cervical Spondylosis; Cervical Radiculopathy; Cervical Myelopathy; Cervical Disc Disease; Cervical Spine Disease; Cervical Stenosis; Cervical Disc Herniation

Keywords

Spine surgery

Outcome Measures

Primary Outcomes (2)

• 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: 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

  24 months

Secondary Outcomes (3)

• Clinical Outcome Success

  24 months

• Rate of Postoperative Dysphagia

  24 months

• Rate of complications attributable to the use of NuVasive instruments, implants, or technologies

  24 months

Study Arms (1)

ACP System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• NuVasive: lead

Study Sites (3)

Duly Health and Care

Naperville, Illinois, 60540, United States

Location

Columbia Orthopedic Group Research

Columbia, Missouri, 65201, United States

Location

Atlantic Brain and Spine

Wilmington, North Carolina, 28401, United States

Location

MeSH Terms

Conditions

Spondylosis; Radiculopathy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Kyle Malone, MS

  Globus Medical Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: May 22, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (3)