Posterior Cervical Fixation Study

General health
Online since 28 October 2024, updated 408 days ago

About this trial

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, ...

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - S5
  • Severity (AIS)?
  • Time since injury
    All
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-S5

    What’s involved

    Type

    Observational

    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.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Mental health and psychosocial factors

    Pain

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more


    • Trial recruitment status
    • By invitation
    • Trial start date
    • 10 May 2022
    • Organisation
    • NuVasive
    • Trial recruitment status
    • By invitation
    • Trial start date
    • 10 May 2022
    • Organisation
    • NuVasive

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more