NuVasive® ACP System Study

Last updated: November 7, 2024
Sponsor: NuVasive
Overall Status: Active - Enrolling

Phase

N/A

Condition

Spondylolisthesis

Spinal Cord Disorders

Radiculopathy

Treatment

N/A

Clinical Study ID

NCT05066711
NUVA.ACP0721
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 ACPSystem in conjunction with a NuVasive interbody implant or vertebral bodyreplacement device (VBR), or a structural bone allograft spacer, for treatment ofany of the following conditions:

  3. degenerative disc disease, as defined by neck pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographic studies

  4. trauma (including fractures)

  5. tumors involving the cervical spine

  6. cervical spinal deformity (kyphosis, lordosis, or scoliosis)

  7. failed previous cervical fusion(s) (e.g., pseudoarthrosis)

  8. cervical spondylolisthesis

  9. cervical spinal stenosis

  10. Able to undergo surgery based on physical exam, medical history, and surgeonjudgment

  11. Understands the conditions of enrollment and is willing to sign an informed consentform to participate in the study

Exclusion

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'scompensation 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 conditionthat 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 Design

Total Participants: 75
Study Start date:
May 22, 2022
Estimated Completion Date:
January 30, 2026

Study 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.

Connect with a study center

  • Duly Health and Care

    Naperville, Illinois 60540
    United States

    Site Not Available

  • Columbia Orthopedic Group Research

    Columbia, Missouri 65201
    United States

    Site Not Available

  • Atlantic Brain and Spine

    Wilmington, North Carolina 28401
    United States

    Site Not Available

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