Posterior Cervical Fixation Study

NCT ID: NCT04770571

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2028-11-30

Brief Summary

The objective of this study is to evaluate the safety and performance of occipito-cervico-thoracic spine surgery using posterior fixation as measured by reported complications, radiographic outcomes, and patients reported outcomes (PROs).This study is being undertaken to identify possible residual risks and to clarify mid-to long-term clinical performance that may affect the benefit/risk ratio of posterior fixation systems.

Detailed Description

This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of select occipito-cervico-thoracic posterior fixation systems in patients who undergo posterior fixation fusion 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 traumatic, reconstructive, and/or tumor conditions in the craniocervical, cervical, and/or upper thoracic spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled in the study, subjects will undergo posterior occipito-cervico-thoracic fixation surgery using one of the NuVasive posterior fixation systems (Vuepoint II OCT or Reline-C) based on the surgeon's standard of care. At least 150 subjects (a minimum of 75 in each implant arm) will be enrolled and will be followed for 24 months after the surgery.

Conditions

Degenerative Disc Disease; Craniocervical Injuries; Cervical Radiculopathy; Cervical Disc Disease; Cervical Fusion; Cervical Spine Disease; Cervical Myelopathy; Cervical Instabilities Spine; Thoracic Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Vuepoint II OCT

observational study

Intervention Type: DEVICE

observational

Reline-C

observational study

Intervention Type: DEVICE

observational

Interventions

observational study

observational

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients who are ≥18 years of age at the time of consent

2. Have planned craniocervical, cervical (C1 to C7), and/or upper thoracic (T1-T3) spine surgery using posterior fixation planned for treatment of any of the following conditions:

1. traumatic spinal fractures and/or traumatic dislocations

2. instability or deformity

3. failed previous fusions (e.g., pseudoarthrosis)

4. tumors involving the cervical spine

5. degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability

3. Using one of the following posterior occipito-cervico-thoracic fixation systems (NuVasive, Inc, San Diego, CA):

1. Vuepoint II OCT

2. Reline-C

4. Able to undergo surgery based on physical exam, medical history, and surgeon judgment

5. Understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study

Exclusion Criteria

1. Patient is involved in active litigation relating to the spine (workers' compensation claim is allowed if it is not contested)

2. Use of bone growth stimulators postoperatively

3. Active smoking within 6 weeks of surgery

4. Patient has known sensitivity to materials implanted

5. Systemic or local infection (latent or active) or signs of local inflammation

6. Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment

7. Pregnant, or plans to become pregnant

8. Patient is a prisoner

9. Patient is participating in another clinical study that would confound study data

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NuVasive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyle Malone, MS

Role: STUDY_DIRECTOR

NuVasive

Locations

UC Irvine Medical Center

Orange, California, United States

Hartford Healthcare Bone & Joint Institute

Hartford, Connecticut, United States

MedStar Health Research Institute

Hyattsville, Maryland, United States

NY Spine Institute

New York, New York, United States

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Houston Methodist

Houston, Texas, United States

Countries

United States

Other Identifiers

NUVA.PCF1020

Identifier Type: -

Identifier Source: org_study_id