Does duroplasty improve outcomes after spinal cord injury?

Plain English Summary

Background and study aims
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.

Who can participate?
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.

What does the study involve?
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.

What are the possible benefits and risks of participating?
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.

Where is the study run from?
The study will be managed by the Surgical Intervention Trials Unit (SITU), the University of Oxford (UK) and will be supported by the Oxford Clinical Trials Unit (OCTRU) (UK). St Georges University of London (UK) is the Study Sponsor.

When is the study starting and how long is it expected to run for?
From January 2021 to December 2026

Who is funding the study?
The National Institute for Health Research (UK) through NIHR EME, an MRC and NIHR partnership
Wings for Life

Who is the main contact?
1. Prof. Marios Papadopoulos (Co-Chief Investigator)
mpapadop@sgul.ac.uk
2. Dr. Samira Saadoun (Co-Chief Investigator)
ssaadoun@sgul.ac.uk
3. Miss Melody Chin (Trial manager)
discus@nds.ox.ac.uk

Study website

Contact information

Prof Marios Papadopoulos
Scientific

Department of Neurosurgery
Atkinson Morley Wing
St. George’s Hospital NHS Foundation Trust
Blackshaw Road
London
SW17 0QT
United Kingdom

ORCID ID	0000-0001-9174-4176
Phone	+44 (0)20 8725 4179
Email	mpapadop@sgul.ac.uk

Dr Samira Saadoun
Scientific

Molecular and Clinical Sciences Research Institute
St. George's, University of London
Jenner Wing, Room 1.234
Cranmer Terrace
London
SW17 0RE
United Kingdom

ORCID ID	0000-0002-5480-5678
Phone	+44 (0)20 8672 1255
Email	ssaadoun@sgul.ac.uk

Miss Melody Chin
Public

DISCUS Trial manager
Surgical Intervention Trials Unit (SITU)
University of Oxford
Botnar Research Centre
Nuffield Orthopaedic Centre
Old Road
Headington
Oxford
OX3 7LD
United Kingdom

Phone	+44 (0)79 17100953
Email	discus@nds.ox.ac.uk

Miss Melody Chin
Public

DISCUS Trial manager
Surgical Intervention Trials Unit (SITU)
University of Oxford
Botnar Research Centre
Nuffield Orthopaedic Centre
Old Road
Headington
Oxford
OX3 7LD
United Kingdom

Phone	+44 (0)79 17100953
Email	melody.chin@nds.ox.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• Austria
• Belgium
• Denmark
• England
• Israel
• Northern Ireland
• Scotland
• Spain
• Sweden
• United Kingdom

Study participating centres

Sponsor information

St George's, University of London
Hospital/treatment centre

Joint Research & Enterprise Services
St George's, University of London and St George's University Hospitals NHS Foundation Trust
Cranmer Terrace
Tooting
London
SW17 0RE
England
United Kingdom

Phone	+44 (0)2082666866
Email	researchgovernance@sgul.ac.uk
Website	http://www.sgul.ac.uk/
"ROR"	https://ror.org/040f08y74

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

24/09/2024: The following changes were made:
1. The following international study participating centres: Shaare Zedek Medical Centre, Aarhus University Hospital, Salzburg University Hospital, Skåne University Hospital, UZ Leuven, Kepler University Hospital, Hadassah Medical Centre, and 12 de Octubre Hospital.
2. The following countries of recruitment were added: Israel, Denmark, Austria, Sweden, Belgium and Spain.
3. Wings for Life was added as the charity funding all the international non-UK sites.
12/09/2024: The following study participating centres were removed: South Tees Hospitals NHS Foundation Trust, Oxford University Hospitals NHS Foundation Trust, North Bristol NHS Trust, Lancashire Teaching Hospitals NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust, University Hospital of Coventry and Warwickshire NHS Trust, University Hospital Southampton NHS Foundation Trust, University Hospitals Plymouth NHS Trust, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, University Hospitals Of North Midlands NHS Trust, Belfast Health & Social Care Trust, Buckinghamshire Healthcare NHS Trust, and Salisbury NHS Foundation Trust.
09/08/2023: Publication reference added.
22/09/2022: Internal review.
16/09/2022: A study contact has been changed and the plain English summary updated accordingly.
14/10/2021: The following changes have been made:
1. The trial website has been added.
2. The recruitment start date has been changed from 01/10/2021 to 08/10/2021.
13/07/2021: The following changes have been made:
1. The ethics approval date has been added.
2. The recruitment start date has been changed from 01/07/2021 to 01/10/2021.
12/07/2021: The ClinicalTrials.gov number has been added.
18/05/2021: Trial’s existence confirmed by the National Institute for Health Research (NIHR).