NuVasive® ACP System Study

Enrolling by invitation

Conditions studied: Cervical Spondylosis, Cervical Radiculopathy, Cervical Myelopathy, Cervical Disc Disease, Cervical Stenosis, Cervical Disc Herniation, Cervical Spine Disease

In brief

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).

Key facts

Study ID

NCT05066711

Run by

NuVasive

People needed

75

Starts

2022-05-22

Expected to finish

2027-06-30

Last updated by the study team

2025-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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