Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

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.

Keywords

Degenerative Disc Disease, Craniocervical Injuries, Cervical Radiculopathy, Cervical Disc Disease, Cervical Fusion, Cervical Spine Disease, Cervical Myelopathy, Cervical Instabilities Spine, Thoracic Injury, Spinal Diseases, Intervertebral Disc Degeneration, Radiculopathy, Spinal Cord Diseases, Trauma, Nervous System, Wounds and Injuries, Thoracic Injuries, Vuepoint II OCT, Reline-C

Eligibility

You can join if…

Open to people ages 18 years and up

  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:
  3. traumatic spinal fractures and/or traumatic dislocations
  4. instability or deformity
  5. failed previous fusions (e.g., pseudoarthrosis)
  6. tumors involving the cervical spine
  7. 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
  8. Using one of the following posterior occipito-cervico-thoracic fixation systems (NuVasive, Inc, San Diego, CA):
  9. Vuepoint II OCT
  10. Reline-C
  11. Able to undergo surgery based on physical exam, medical history, and surgeon judgment
  12. Understands the conditions of enrollment and is willing to sign an informed consent form to participate in the study

You CAN'T join if...

  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

Locations

  • UC Irvine Medical Center
    Orange California 92868 United States
  • NY Spine Institute
    New York New York 10003 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
NuVasive
ID
NCT04770571
Study Type
Observational
Participants
Expecting 150 study participants
Last Updated