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Enrolling by invitation NCT05066711

NuVasive® ACP System Study

— Observational Cervical Spondylosis Cervical Radiculopathy Cervical Myelopathy Cervical Disc Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cervical Spondylosis, Cervical Radiculopathy, Cervical Myelopathy, Cervical Disc Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Complications NuVasive ACP System [Time frame: 24 months]
  • Radiographic Success [Time frame: 24 months]
Secondary outcome measures (3)
  • Clinical Outcome Success [Time frame: 24 months]
  • Rate of Postoperative Dysphagia [Time frame: 24 months]
  • Rate of complications attributable to the use of NuVasive instruments, implants, or technologies [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 3 centers
  • Duly Health and Care — Naperville
  • Columbia Orthopedic Group Research — Columbia
  • Atlantic Brain and Spine — Wilmington

Identifiers

NCT: NCT05066711 · NUVA.ACP0721

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗