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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Samira Saadoun
+44 (0)20 8672 1255
ssaadoun@sgul.ac.uk


Miss Melody Chin
+44 (0)79 17100953
melody.chin@nds.ox.ac.uk


Prof Marios Papadopoulos
+44 (0)20 8725 4179
mpapadop@sgul.ac.uk


Miss Melody Chin
+44 (0)79 17100953
discus@nds.ox.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Does duroplasty improve outcomes after spinal cord injury?
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Does duroplasty improve outcomes after spinal cord injury?

Recruiting

Open to: All Genders

Age: Adult

Sheffield Cambridge Birmingham Liverpool London Stanmore Hull Wakefield London Oswestry Aberdeen Southport London Nottingham Salford Glasgow Edinburgh Leeds London Jerusalem Aarhus Salzburg Skåne Leuven - Jerusalem $location.addressLine3

Medical Conditions

Traumatic Spinal Cord Injury (TSCI)

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Acute traumatic spinal cord injury is a devastating condition that causes permanent disability (paralysis, numbness) and other complications such as chest and urine infections, pressure ulcers and loss of bladder and bowel control. In the UK, one person suffers a spinal cord injury every 8 hours and there are about 40,000 people living with long-term disabilities from cord injuries. Currently, there are no treatments shown to benefit patients with spinal cord injuries. After the injury, the spinal cord swells and the pressure inside the cord rises, which obstructs the flow of blood to the injury site, causing further damage. Surgery aims to straighten and fix the spine with screws and rods to reduce pressure on the injured cord. Based on our research, we think that the tough membrane around the spinal cord (dura) is a major, but unappreciated, cause of cord pressure after injury. An operation called duroplasty involves opening the dura and stitching a patch of artificial dura to expand the space around the swollen spinal cord. We have shown in a small study of patients that performing this operation safely and effectively reduces pressure on the injured cord. A similar operation is routinely used to decompress the swollen brain after brain injury, but, for spinal cord injury, standard treatment is surgery on the spine without the duroplasty. In this study, we will investigate whether duroplasty helps improve patient outcomes after spinal cord injury. We predict that patients who had standard treatment plus duroplasty will have better outcomes than those who had standard treatment alone.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

08 Oct 2021 30 Jun 2025

Publications

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37550727/ (added 09/08/2023)

This is a randomised controlled trial. This means that those that agree to take part will be allocated by chance (like tossing a coin) to standard treatment or standard treatment plus duroplasty. Patients will not be aware which treatment they receive. The trial aims to recruit 222 patients aged 16 years or older, with severe spinal cord injuries in the neck from 26 NHS hospitals. Consent will be obtained from the patient or their family and surgery will be done as soon as possible (within 72 hours of injury). After agreeing to take part in the trial, patients will be asked to fill in questionnaires about their quality of life and will also be assessed on how well they can use their hands, walk and control their bladder and bowel. Some of these assessments will be repeated at 3, 6, and 12 months after surgery. These assessments will be combined with planned hospital visits and some questionnaires will be completed over the phone or by email. Some patients will also be asked to take part in a smaller study which involves placing probes at the injury site.


Adult patients (aged 16 years or older) with severe spinal cord injuries in the neck who require surgery within 72 h and agree to participate in the study. Patients with a spinal cord injury below the neck, co-existing major health conditions or co-existing medical conditions affecting the brain and/or spinal cord, and torn tough membrane around the spinal cord will not be eligible to participate.

You can take part if:



You may not be able to take part if:


1. Dural tear due to traumatic spinal cord injury (TSCI)2. Life-limiting or rehabilitation-restricting co-morbidities3. Thoracic or lumbar traumatic spinal cord injury4. Other central nervous system disease


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Sheffield Teaching Hospitals NHS Foundation Trust
    Northern General Hospital Herries Road
    Sheffield
    S5 7AU
  • Cambridge University Hospitals NHS Foundation Trust
    Cambridge Biomedical Campus Hills Road
    Cambridge
    CB2 0QQ
  • University Hospitals Birmingham NHS Foundation Trust
    Queen Elizabeth Hospital Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW
  • The Walton Centre NHS Foundation Trust
    Lower Lane
    Liverpool
    L9 7LJ
  • Barts Health NHS Trust
    The Royal London Hospital 80 Newark Street
    London
    E1 2ES
  • Royal National Orthopaedic Hospital NHS Trust
    Brockley Hill
    Stanmore
    HA7 4LP
  • Hull University Teaching Hospitals NHS Trust
    Hull Royal Infirmary Anlaby Road
    Hull
    HU3 2JZ
  • Mid Yorkshire Hospitals NHS Trust
    Pinderfields Hospital Aberford Road
    Wakefield
    WF1 4DG
  • King's College Hospital NHS Foundation Trust
    King's College Hospital Denmark Hill
    London
    SE5 9RS
  • The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
    Gobowen
    Oswestry
    SY10 7AG
  • NHS Grampian
    Summerfield House 2 Eday Road
    Aberdeen
    AB15 6RE
  • Southport and Ormskirk Hospital NHS Trust
    Town Lane
    Southport
    PR8 6PN
  • St George’s University Hospitals NHS Foundation Trust
    St George’s Hospital Blackshaw Road Tooting
    London
    SW17 0QT
  • Nottingham University Hospitals NHS Trust
    Trust Headquarters Queens Medical Centre Derby Road
    Nottingham
    NG7 2UH
  • Salford Royal NHS Foundation Trust
    Salford Royal Stott Lane
    Salford
    M6 8HD
  • NHS Greater Glasgow and Clyde
    J B Russell House Gartnavel Royal Hospital 1055 Great Western Road
    Glasgow
    G12 0XH
  • NHS Lothian
    Waverley Gate 2-4 Waterloo Place
    Edinburgh
    EH1 3EG
  • LGI GPS IN A+E
    Leeds General Infirmary Great George Street
    Leeds
    LS1 3EX
  • Imperial College Healthcare NHS Trust
    The Bays St Marys Hospital South Wharf Road
    London
    W2 1BL

We cannot promise that duroplasty will help, but we predict that it will lower the build-up of damaging pressure and improve the blood flow to the spinal cord. We do not know whether this improves recovery. The trial is designed to find out whether duroplasty improves recovery after spinal cord injury or not.
There is a small risk that the duroplasty will cause spinal fluid to leak, which may need another procedure, e.g. insertion of a drain tube to the spine for a few days. Expansion duroplasty is a reconstructive operation that closes openings in the dura membrane that surrounds the spinal cord and, therefore, the risk is low.
The chance of being harmed from the probes is very low, less than 1 in 100. We know this because we have already done such recordings from many (more than 80) patients without causing damage. Nevertheless, there is a small chance that the probes cause damage to the spinal cord. The probes might get infected and the infection might spread to the spinal fluid that may need antibiotic treatment. After removing the probes, there is a small risk of a spinal fluid leak. If this happens, another small operation may be needed to stop the leak.

Prof Marios Papadopoulos
+44 (0)20 8725 4179
mpapadop@sgul.ac.uk


Dr Samira Saadoun
+44 (0)20 8672 1255
ssaadoun@sgul.ac.uk


Miss Melody Chin
+44 (0)79 17100953
melody.chin@nds.ox.ac.uk


Miss Melody Chin
+44 (0)79 17100953
discus@nds.ox.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by St George's, University of London and funded by National Institute for Health Research; Wings for Life.



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Read full details for Trial ID: ISRCTN25573423

Or CPMS 48627

Last updated 24 September 2024

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