Clinical trial NCT05066711: NuVasive® ACP System Study
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cervical Spondylosis
Cervical Radiculopathy
Cervical Myelopathy
Cervical Disc Disease
Cervical Stenosis
Cervical Disc Herniation
Cervical Spine Disease
Keywords: Spine surgery
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2021-10-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Complications NuVasive ACP System
timeFrame: 24 months
measure: Radiographic Success
timeFrame: 24 months
Secondary outcomes:
measure: Clinical Outcome Success
timeFrame: 24 months
measure: Rate of Postoperative Dysphagia
timeFrame: 24 months
measure: Rate of complications attributable to the use of NuVasive instruments, implants, or technologies
timeFrame: 24 months
Other outcomes:
Locations:
city: Naperville
country: United States
facility: Duly Health and Care
state: Illinois
city: Columbia
country: United States
facility: Columbia Orthopedic Group Research
state: Missouri
city: Wilmington
country: United States
facility: Atlantic Brain and Spine
state: North Carolina
Study officials:
affiliation: Globus Medical Inc
name: Kyle Malone, MS
role: STUDY_DIRECTOR
References: