Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis

Surgery
Standing/walking/mobility
Online since 2 November 2021, updated 846 days ago

About this trial

This is a surgical study recruiting individuals with acute cervical (neck area) spinal cord injuries to evaluate the timing of spine surgery to relieve pressure on the spinal cord (decompression). The study will compare decompressive spine surgery performed within 48 hours of injury with surgery performed 15 days after injury. Participants will be randomly allocated to one of the two groups: early surgery or later surgery. The decompression surgery will be performed similarly in both groups. Assessment will occur over a period of two years and will measure motor and sensory recovery, as well as disability and functional outcome scores.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - T1
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≤ 15 days
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T1
    Additionally, participants must
    have an acute spinal cord injury capable of undergoing surgical decompression within 48 hours at the time of randomization.
    have a neurological level of injury between C2-T1
    have one of the following ASIA impairment scale (AIS):

    What’s involved

    Type

    Surgery

    Details

    The participant will be randomly assigned to undergo spinal decompression surgery within 48 hours of SCI or wait until 15 days after injury for surgery. After the post-surgical care, outcome assessments will be done at 4 time points in the following 2 years.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Arm/hand function

    Bladder health

    Bowel health

    General health

    Mental health

    Pain

    Sensory function

    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
    • Recruiting
    • Trial start date
    • 1 Jul 2016
    • Organisation
    • Nantes University Hospital
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Jul 2016
    • Organisation
    • Nantes University Hospital

    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