NuVasive® ACP System Study

Sponsor

NuVasive (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05066711

Collaborator

(none)

Enrollment

Location

44.3

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cervical Spondylosis Cervical Radiculopathy Cervical Myelopathy Cervical Disc Disease Cervical Stenosis Cervical Disc Herniation Cervical Spine Disease

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

75 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

May 22, 2022

Anticipated Primary Completion Date :

Jan 30, 2025

Anticipated Study Completion Date :

Jan 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
ACP System

Outcome Measures

Primary Outcome Measures

Complications NuVasive ACP System [24 months]
Rate of complications (i.e., safety) attributable to use of the NuVasive ACP System
Radiographic Success [24 months]
Proportion of subjects with radiographic success at: Latest time point available for patients undergoing surgery to treat advanced stage tumors 24 months postoperative for subjects undergoing surgery to treat instabilities, traumatic spinal fractures, failed previous fusions, or degenerative disease

Secondary Outcome Measures

Clinical Outcome Success [24 months]
Percentage of subjects meeting minimal clinically important difference (MCID) and/or substantial clinical benefit (SCB) thresholds for each PRO: neck and arm pain (measured by visual analog scale (VAS)), disability (measured by neck disability index (NDI)), and overall physical and mental health (measured by PROMIS-10)
Rate of Postoperative Dysphagia [24 months]
Rate of postoperative dysphagia as measured by the Eating Assessment Tool (EAT-10)
Rate of complications attributable to the use of NuVasive instruments, implants, or technologies [24 months]
Rate of complications attributable to the use of NuVasive instruments, implants, or technologies

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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