Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling

Surgery
General health
Online since 3 April 2022, updated 835 days ago

About this trial

This is a clinical trial to test the effect on general neurological outcomes of a surgical procedure early after a cervical spinal cord injury. After SCI, the spinal cord has a natural reaction of swelling. The standard surgical procedure aims to reduce the pressure on the spinal cord by removing bony structures which help to decompress the spinal cord as it swells. This study explores the additional effect of the opening the membrane (dura) that surrounds the spinal cord to further reduce pressure due to swelling. Investigators will assess other effects of the surgical procedure including blood flow to the injured cord, energy use by its cells, and inflammation. If included, participants will randomly be assigned to one of two study groups: a) undergoing the standard bony decompression within 72 hours of SCI; or b) undergoing the bony decompression plus opening of the membrane surrounding the spinal cord (duroplasty). Final testing, including various measurements of motor function, will be performed after 12 months.

Included participants

Gender
All
Age
≥ 16 years
Injury level
C2 - T1
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    Time since injury
    ≤ 72 hours
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C2-T1
    Additionally, participants must
    require surgery that includes laminectomy

    What’s involved

    Type

    Surgery

    Details

    - undergo an additional surgical procedure, combined with the surgery they will normally have within 72 hours of traumatic SCI

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Bladder health/function

    Mental health and psychosocial factors

    Sensory function

    Standing/walking/mobility

    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
    • 8 Oct 2021
    • Organisation
    • St George's, University of London
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 8 Oct 2021
    • Organisation
    • St George's, University of London

    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