NuVasive® ACP System Study

NCT ID: NCT05066711

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-22
• Study Completion Date: 2027-06-30

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).

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.

Conditions

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

Keywords

Spine surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ACP System

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NuVasive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyle Malone, MS

Role: STUDY_DIRECTOR

Globus Medical Inc

Locations

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

Countries

United States

Other Identifiers

NUVA.ACP0721

Identifier Type: -

Identifier Source: org_study_id