NuVasive® ACP System Study

Cervical Radiculopathy Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05066711
• Other study ID #: NUVA.ACP0721
• Status: Enrolling by invitation
• Start date: May 22, 2022
• Est. completion date: January 30, 2026

Study information

• Verified date: February 2024
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: January 30, 2026
• Est. primary completion date: January 30, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Disc Disease
• Cervical Disc Herniation
• Cervical Myelopathy
• Cervical Radiculopathy
• Cervical Spine Disease
• Cervical Spondylosis
• Cervical Stenosis
• Intervertebral Disc Displacement
• Radiculopathy
• Spinal Cord Diseases
• Spinal Diseases
• Spondylosis

Locations

Country	Name	City	State
United States	Columbia Orthopedic Group Research	Columbia	Missouri
United States	Duly Health and Care	Naperville	Illinois
United States	Atlantic Brain and Spine	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications NuVasive ACP System	Rate of complications (i.e., safety) attributable to use of the NuVasive ACP System	24 months
Primary	Radiographic Success	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	24 months
Secondary	Clinical Outcome Success	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)	24 months
Secondary	Rate of Postoperative Dysphagia	Rate of postoperative dysphagia as measured by the Eating Assessment Tool (EAT-10)	24 months
Secondary	Rate of complications attributable to the use of NuVasive instruments, implants, or technologies	Rate of complications attributable to the use of NuVasive instruments, implants, or technologies	24 months