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DISCUS Trial

About DISCUS

DISCUS is an emergency randomised controlled trial designed to compare two different types of surgery for Traumatic Spinal Cord Injury (TSCI) – surgery including laminectomy and duroplasty versus surgery including laminectomy.

Acute TSCI 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 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.

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.

We have shown in a small study of patients that performing dural decompression (duroplasty) safely and effectively reduces pressure on the injured cord. We predict that patients who had standard treatment plus duroplasty will have better outcomes than those who had standard treatment alone. 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 duroplasty.

Trial details

DISCUS is a Phase III, multicentre, international randomised controlled trial (RCT) which will investigate whether duroplasty helps improve patient outcomes after spinal cord injury.

Eligible patients will be randomised into one of two arms and followed up for 12 months after surgery. Assessments will include those which are offered as part of standard care, and some additional questionnaires looking at health-related quality of life.

Eligible patients

We aim to recruit 222 patients aged 16 or older, with severe cervical spinal cord injuries. The local surgeons will have to assess whether the patient requires and is suitable for this kind of surgery, which will be done as soon as possible (within 72 hours of injury). Consent will need to be obtained from patients, or their family.

Mechanistic sub-study

DISCUS includes an optional study for at least 50 patients who take part in the main trial. The aim of the mechanistic study is to determine how duroplasty improves outcome, i.e. whether duroplasty reduces cord compression, improves blood flow to the injured cord perfusion, improves cord metabolism and reduces cord inflammation.

Recruiting Sites

We currently have 15 Major Trauma Centres (MTC) and seven Rehab sites open in UK.

MTC

Rehab

St George’s Hospital, LondonLondon Spinal Cord Injury Centre, London
King's College Hospital, LondonQueen Elizabeth National Spinal Injuries Unit, Glasgow
St Mary's Hospital, LondonNational Spinal Injuries Centre, Stoke Mandeville
Leeds General Infirmary, LeedsYorkshire Regional Spinal Injuries Centre, Pinderfields
Queen Elizabeth University Hospital, Glasgow
Midlands Centre for Spinal Injuries, RJAH, Birmingham
The Royal London Hospital, LondonPrincess Royal Spinal Cord Injuries Centre, Sheffield
Aberdeen Royal Infirmary, AberdeenNorth West Regional Spinal Injuries Centre, Southport
Hull Royal Infirmary, Hull
Salford Royal Hospital, Salford
Addenbrookes Hospital, Cambridge
Sheffield Teaching Hospitals, Sheffield
The Walton Centre, Liverpool
Queen Elizabeth Hospital, Birmingham
Queen’s Medical Centre, Nottingham
Royal Infirmary of Edinburgh, Edinburgh

We also have four international sites open so far and we anticipate more will join very soon.

International 

Shaare Zedek Medical Centre, Jerusalem
Aarhus University Hospital, Denmark
University Hospital Salzburg, Austria
Skanes University Hospital Lund, Sweden
UZ Leuven, Belgium
Kepler University Hospital Linz, Austria

Funding and sponsor

DISCUS is funded by the National Institute of Health and Care Research (NIHR)’s Efficacy and Mechanism Evaluation (EME) programme and sponsored by St George’s University of London in UK. The international funder for DISCUS is Wings for Life charity.

Trial Co-Applicants

Dr Matthew Gallagher, Dr Ayokunle Ogungbemi, Mr Stephen Dowd, Dr Dimitrios Sampanis, Dr Maurizio Belci, Dr Julia Wade, Dr Argyro Zoumprouli, Ms Lucy Davies

Further information

For more information, please email us at discus@nds.ox.ac.uk or follow us on Twitter/X for updates!

We are taking part in the NIHR Associate PI scheme.