Posterior Cervical Fixation Study

A Prospective, Multicenter Study Evaluating the Safety and Performance of Posterior Fixation in Trauma, Reconstructive, and Tumor Surgery of the Occipito-cervico-thoracic Spine

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Degenerative Disc Disease; Craniocervical Injuries; Cervical Radiculopathy; Cervical Disc Disease; Cervical Fusion; Cervical Spine Disease; Cervical Myelopathy; Cervical Instabilities Spine; Thoracic Injury

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • UC Irvine Medical Center
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • MedStar Health Research Institute
  • New York
    • New York, New York, United States, 10003
      • NY Spine Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Vuepoint II OCT
Reline-C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Latest timepoint 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for neck/arm pain measured by visual analog scale (VAS).	Neck and arm pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet MCID (2.5 points and 2.5 points respectively) where 0 is "No Pain" and 10 is "Unbearable Pain".	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.	Overall physical and mental health measured by PROMIS-10 will be assessed to determine the percentage of subjects who meet MCID (5 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	24 months
Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline for disability measured by the neck disability index.	Disability measured by the neck disability index (NDI) will be assessed to determine the percentage of subjects who meet SCB (9.5 points) where a higher score on the NDI indicates a more severe disability.	24 months
Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies	Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies.	24 months
Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the neck disability index.	Disability measured by the neck disability index (NDI) will be assessed to determine the percentage of subjects who meet MCID (7.5 points) where a higher score on the NDI indicates a more severe disability.	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).	Neck and arm pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet SCB (3.5 points) where 0 is "No Pain" and 10 is "Unbearable Pain".	24 months
Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline measured by overall physical and mental health from PROMIS-10.	Overall physical and mental health measured by PROMIS-10 will be assessed to determine the percentage of subjects who meet SCB (6.8 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	24 months

Collaborators and Investigators

• Sponsor: NuVasive
• Investigators: Study Director: Kyle Malone, MS, NuVasive

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Bone Diseases; Wounds and Injuries; Intervertebral Disc Degeneration; Radiculopathy; Spinal Cord Diseases; Spinal Diseases; Trauma, Nervous System; Thoracic Injuries
• Other Study ID Numbers: NUVA.PCF1020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No