NuVasive® ACP System Study

• Conditions: Cervical Stenosis; Cervical Radiculopathy; Cervical Myelopathy; Cervical Disc Disease; Cervical Disc Herniation; Cervical Spondylosis; Cervical Spine Disease

• Registration Number: NCT05066711
• Lead Sponsor: NuVasive

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.

Study Timeline

• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-10-04
• Study Start: 2022-05-22
• Status Verified: 2024-02
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11
• Primary Completion: 2025-01-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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: 1. Latest time point available for patients undergoing surgery to treat advanced stage tumors; 2. 24 months postoperative for subjects undergoing surgery to treat instabilities, traumatic spinal fractures, failed previous fusions, or degenerative disease

Secondary Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (3)

Columbia Orthopedic Group Research; 🇺🇸 Columbia, Missouri, United States

Duly Health and Care; 🇺🇸 Naperville, Illinois, United States

Atlantic Brain and Spine; 🇺🇸 Wilmington, North Carolina, United States