Posterior Cervical Fixation Study

NCT04770571 | Enrolling By Invitation FDA Device

• 1 other identifier: NUVA.PCF1020
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Complications of Posterior Fixation System

  Rate of complications (i.e., safety) attributable to the use of the associated posterior fixation system.

  24 months

• Radiographic Success

  The proportion of subjects with apparent radiographic success at: 1. Latest timepoint 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

  24 months

Secondary Outcomes (7)

• Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for neck/arm pain measured by visual analog scale (VAS).

  24 months

• Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the neck disability index.

  24 months

• Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline measured by overall physical and mental health from PROMIS-10.

  24 months

• Percentage of subjects meeting substantial clinical benefit (SCB) for neck/arm pain as compared to baseline for neck/arm pain measured by visual analog scale (VAS).

  24 months

• Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline for disability measured by the neck disability index.

  24 months

Study Arms (2)

Vuepoint II OCT

Device: observational study

Reline-C

Device: observational study

Interventions

observational study DEVICE

observational

Reline-C; Vuepoint II OCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Enrolled 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. Evaluable Population The Evaluable Populations will include all subjects who: * Were included in the Enrolled Populations, * Completed the study, and * Had no major protocol deviations.

You may qualify if:

• Patients who are ≥18 years of age at the time of consent
• 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:
• traumatic spinal fractures and/or traumatic dislocations
• instability or deformity
• failed previous fusions (e.g., pseudoarthrosis)
• tumors involving the cervical spine
• 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
• Using one of the following posterior occipito-cervico-thoracic fixation systems (NuVasive, Inc, San Diego, CA):
• Vuepoint II OCT
• Reline-C
• 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

You may not qualify if:

• Patient is involved in active litigation relating to the spine (workers' 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

Sponsors & Collaborators

• NuVasive: lead

Study Sites (7)

UC Irvine Medical Center

Orange, California, 92868, United States

Location

Hartford Healthcare Bone & Joint Institute

Hartford, Connecticut, 06106, United States

Location

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

NY Spine Institute

New York, New York, 10003, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Trauma, Nervous System; Radiculopathy; Klippel-Feil Syndrome; Thoracic Injuries

Interventions

Observation

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Dysostoses; Bone Diseases, Developmental; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Kyle Malone, MS

  NuVasive

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: May 10, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)