AzTrials
AzTrials

Spinal Cord InjuriesDISCUSNCT04936620

Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling

A study testing Duroplasty and Spinal surgery in people with Spinal Cord Injuries, run by St George's, University of London at 34 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

QUESTION. Does duroplasty improve outcome after spinal cord injury? WHAT DO WE STUDY? We will investigate whether performing a surgical procedure called duroplasty improves outcomes after spinal cord injury. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Duroplasty and Spinal surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
34 sitesin 12 countries
Study dates
8 Oct 2021to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥16 years
  • Severe cervical (C2 - T1) traumatic spinal cord injury (AIS grade A-C)
  • Deemed to require and be suitable for surgery that includes laminectomy by local surgeon
  • Surgery within 72 hours of traumatic spinal cord injury
  • Able to provide informed consent or consultee declaration or proxy consent.

Who cannot join

  • Dural tear due to traumatic spinal cord injury
  • Life-limiting or rehabilitation-restricting co-morbidities
  • Thoracic or lumbar traumatic spinal cord injury
  • Other central nervous system disease

Trial locations and contacts

34 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Sophie Reynolds contact

079 17100953

discus@nds.ox.ac.uk

Ghazal Ebrat contact

gebrat@sgul.ac.uk

34 sites in 12 countries

United Kingdom18 sites, 13 recruiting

  • National Spinal Injuries Centre

    Aylesbury

    Active, not recruiting

  • Queen Elizabeth Hospital Birmingham

    Birmingham

    Vladimir Petrik

    Recruiting

  • Addenbrooke's Hospital

    Cambridge

    Ivan Timofeev

    Recruiting

  • Royal Infirmary of Edinburgh

    Edinburgh

    Andreas Demetriades

    Recruiting

  • Queen Elizabeth University Hospital

    Glasgow

    Likhith Alakandy

    Recruiting

  • Hull Royal Infirmary

    Hull

    Vasileios Arzoglou

    Recruiting

  • Leeds General Infirmary

    Leeds

    Christopher Derham

    Recruiting

  • The Walton Centre

    Liverpool

    Martin Wilby

    Recruiting

  • St George's Hospital

    London

    Marios C Papadopoulos, MD, 02087254179, mpapadop@sgul.ac.uk

    Marios Papadopoulos

    Recruiting

  • St Mary's Hospital

    London

    Haider Kareem

    Recruiting

  • The London Spinal Cord Injury Centre

    London

    Active, not recruiting

  • The Royal London Hospital

    London

    Christopher Uff

    Recruiting

  • Queen's Medical Centre

    Nottingham

    Daniel D'Aquino

    Recruiting

  • Midlands Centre for Spinal Injuries,

    Oswestry

    Active, not recruiting

  • Salford Royal

    Salford

    Shrijit Panikkar

    Recruiting

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield

    Marcel Ivanov

    Rohit Bhide

    Recruiting

  • North West Regional Spinal Injuries Centre

    Southport

    Active, not recruiting

  • Pinderfields Hospital

    Wakefield

    Active, not recruiting

Other trials in United Kingdom

Austria4 sites, 4 recruiting

  • Universität Klinik für Neurochirurgie

    Innsbruck

    Claudius Thome

    Recruiting

  • Kepler University Hospital

    Linz

    Wolfgang Senker

    Recruiting

  • University Hospital Salzburg

    Salzburg

    Lukas Grassner

    Recruiting

  • St Polten University Hospital

    Sankt Pölten

    Franz Marhold, 43 2742/9004-12961, neurochirurgie@stpoelten.lknoe.at

    Recruiting

Other trials in Austria

Germany2 sites, 2 recruiting

  • BG Unfallklinik Frankfurt am Main

    Frankfurt

    Jonathan Neuhoff

    Recruiting

  • Klinik und Poliklinik für Neurochirurgie Universitätsklinikum Frankfurt, 60596 FRANKFURT AM MAIN

    Frankfurt

    Marcus CZABANKA, Prof Dr Med, 0049 (0) 69 6301 5295, czabanka@med.uni-frankfurt.de

    Marcus CZABANKA, Prof dr Med, czabanka@med.uni-frankfurt.de

    Recruiting

Other trials in Germany

Israel2 sites, 2 recruiting

  • Hadassah Medical Center

    Jerusalem

    Guy Rosenthal

    Recruiting

  • Shaare Zedek Medical Centre

    Jerusalem

    Cezar Mizrahi

    Recruiting

Other trials in Israel

Belgium1 site, 1 recruiting

  • UZ Leuven

    Leuven

    Bart Depreitere

    Recruiting

Other trials in Belgium

China1 site, 1 recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Xiaodong Guo, 027 85726646, xiaodongguo@hust.edu.cn

    Peiran Xue, xuepeiran@outlook.com

    Recruiting

Other trials in China

Czechia1 site, 1 recruiting

  • Masaryk Hospital

    Ústí nad Labem

    Aleš Hejčl, 420477112884, ales.hejcl@kzcr.eu

    Recruiting

Other trials in Czechia

Denmark1 site, 1 recruiting

  • Aarhus University Hospital

    Aarhus

    Mikkel Mylius Rasmussen

    Recruiting

Other trials in Denmark

Finland1 site, 1 recruiting

  • Kuopio University Hospital

    Kuopio

    Nils Danner, 358400911568, Nils.Danner@pshyvinvointialue.fi

    Recruiting

Other trials in Finland

Slovenia1 site, 1 recruiting

  • University Medical Centre Ljubljana

    Ljubljana

    Marko Jug

    Recruiting

Other trials in Slovenia

Spain1 site, 1 recruiting

  • 12 de Octubre University Hospital

    Madrid

    Igor Paredes

    Recruiting

Other trials in Spain

Sweden1 site, 1 recruiting

  • Skåne University Hospital

    Lund

    Niklas Marklund

    Recruiting

Other trials in Sweden

About this study

QUESTION. Does duroplasty improve outcome after spinal cord injury?

WHAT DO WE STUDY? We will investigate whether performing a surgical procedure called duroplasty improves outcomes after spinal cord injury.

Read more

WHY SPINAL CORD INJURY? Spinal cord injury is a devastating condition that causes permanent disability such as paralysis, numbness and loss of bladder and bowel control. Currently, there are no treatments shown to improve outcome after spinal cord injury.

WHAT IS DUROPLASTY? Duroplasty is an operation that involves opening the tough membrane around the cord, called the dura, and stitching a patch of artificial dura to expand the space around the swollen cord.

WHY IS DUROPLASTY BEING STUDIED? Based on our preliminary evidence, we think that the dura causes cord pressure after injury. We have shown in a small study of patients that performing this operation safely and effectively reduces pressure on the injured cord.

WHO IS ELIGIBLE? Adult patients with severe spinal cord injuries in the neck who will have surgery within 72 hours.

WHAT TREATMENT? Those who agree to take part will be allocated by chance (like tossing a coin) to standard treatment or standard treatment plus duroplasty. Some patients will also be asked to take part in a smaller study that involves placing probes at the injury site.

WHERE? Initially, we will recruit patients from U.K. Major Trauma Centres. Most assessments will be done in U.K. Spinal Injury Centres. Later on, we we also started recruiting from overseas.

HOW LONG? We aim to recruit 222 - 260 patients over 4 years. Patients will be followed up for a year.

WHAT DO WE ASSESS? Patients will be assessed (using questionnaires and by examination) how well they can use their hands, walk, control their bladder and bowel and their quality of life. Some of these assessments will be repeated at 3, 6 and 12 months after surgery.

WHAT IS THE OPTIONAL MECHANISTIC STUDY? DISCUS includes an optional study for at least 50 patients who will take part in the randomised controlled 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.

WHAT IS THE OPTIONAL INFORMATION STUDY? For the first two years, a study called QuinteT Recruitment Intervention (QRI) is designed to optimise patient recruitment and informed consent in the trauma setting.

Read the detailed description

RESEARCH QUESTION: After severe traumatic spinal cord injury (TSCI), does the addition of dural decompression to bony decompression (includes laminectomy) improve muscle strength in the limbs at 6 months, compared with bony decompression alone? BACKGROUND: TSCI is a devastating condition that affects about 1,000 people in the UK annually. Most remain disabled, tetraplegic or wheelchair bound and are dependent on carers with significant cost to patients, carers and the NHS. Surgery aims to reduce spinal deformity, stabilise the spine and achieve bony decompression of the cord. To date, no treatments have been shown to improve outcome.

AIMS / OBJECTIVES: The primary aim is to determine if, in patients with acute, severe TSCI, the addition of dural decompression to bony decompression improves muscle strength. We hypothesise that, after TSCI, the cord swells and is compressed against the dura. Secondary objectives are to assess patient impact i.e. functional outcomes, health related quality of life (HRQoL), complication rates and mortality. Mechanistic sub-studies aim to determine if the addition of duroplasty improves cord perfusion, reduces cord ischaemia and cord inflammation.

METHODS: This is a prospective, phase III, multicentre randomised controlled trial (RCT). We aim to recruit 222 adults with acute, severe cervical TSCI (American spinal injuries association Impairment Scale (AIS) grade A, B or C) who will be randomised 1:1 to undergo bony decompression alone versus bony decompression with duroplasty. Patients and assessors will be blinded to study arm. The primary outcome is change in AIS motor score (AMS) at 6 months compared with admission (Delta-AMS); secondary outcomes will assess function (grasp, walking, urinary + anal sphincters), HRQoL, complications, need for further surgery and mortality, assessed at baseline, 3 months, 6 months and 12 months from randomisation. A subgroup of 50 patients (25 per arm) will also have observational monitoring from the injury site using a pressure probe (intraspinal pressure ISP, spinal cord perfusion pressure SCPP) and microdialysis (MD) catheter (cord metabolism: tissue glucose, lactate, pyruvate, lactate-to-pyruvate ratio (LPR), glutamate, glycerol); cord inflammation: tissue chemokines/cytokines. Initially, patients were only recruited from UK major trauma centres (MTCs). DISCUS is now also recruiting patients from International sites.

TIMELINES FOR DELIVERY: The initial study duration was 72 months and includes 6 months set-up, 48 months recruitment, 12 months to complete follow-up and 6 months for data analysis and final reporting of results. There will be a formal stop/go review at month 15 (after 9 months of recruitment) to ensure a minimum of 4 sites have been opened and 8 patients randomised. If these targets are met, the trial will recruit for a further 36 months. Data from the pilot will be included in the final analysis. Recruitment has been extended to end on 30 June 2027.

ANTICIPATED IMPACT AND DISSEMINATION: It is anticipated that the addition of duroplasty to standard of care will improve muscle strength in patients; this has obvious benefits for patients and their carers as well as substantial gains for the NHS and society including economic implications. If this RCT shows that the addition of duroplasty to standard treatment is beneficial, it is anticipated that duroplasty will become standard NHS care in all 26 UK MTCs, and internationally. Participants will be informed of study findings via the Surgical Intervention Trials Unit (SITU) website and the Spinal Injuries Association (SIA).

Being tested
Duroplasty, Spinal surgery
Keywords
Decompression, surgical; Neurosurgery; Paralysis
Medical subject headings
Spinal Cord Injuries, Paralysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DuroplastyProcedure or surgery

    Expansion Duroplasty

  • Spinal surgeryProcedure or surgery

    Spinal surgery including laminectomy

Study groups in NCT04936620
Study groupRoleWhat they receive
DuroplastyActive comparatorDuroplasty (includes Surgery with Laminectomy)
Receives: Procedure: Duroplasty; Procedure: Spinal surgery
No duroplastyActive comparatorNo duroplasty (but includes surgery with Laminectomy)
Receives: Procedure: Spinal surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in AIS motor score

    Change in American Spinal Injury Association Impairment Scale total limb motor score at 6 months

    Measured: 6 months versus baseline

Secondary outcomes (14)

  1. Change in AIS light touch score

    Change in American Spinal Injury Association Impairment Scale total light touch sensory score

    Measured: 6 months versus baseline

  2. Change in AIS pin prick score

    Change in American Spinal Injury Association Impairment Scale total pin prick sensory score

    Measured: 6 months versus baseline

  3. Change in AIS grade

    Change in American Spinal Injury Association grade

    Measured: 6 months versus baseline

  4. CUE-Q

    Capabilities of upper extremity-questionnaire (CUE-Q)

    Measured: 6 months

  5. Grip strength

    Hand grip strength assessed with dynamometer

    Measured: 6 months

  6. WISCI II

    Walking Index for Spinal Cord Injury version ii

    Measured: 6 months

  7. SCIM III

    Spinal Cord Independence Measure version III

    Measured: 6 months

  8. SF-36

    Short Form survey 36

    Measured: 6 months, 12 months

  9. Spinal re-operations

    Number of reoperations on spine

    Measured: 12 months

  10. Adverse events

    Procedure Specific complications and adverse events

    Measured: 12 months

  11. Mortality

    Mortality

    Measured: 12 months

  12. Length of hospital stay

    Length of hospital stay

    Measured: 12 months

  13. MRI

    Magnetic resonance imaging of cervical spine

    Measured: 2 weeks, 6 months

  14. Injury site physiology and metabolism (optional)

    Optional mechanistic study: Mean daily intraspinal pressure, spinal cord perfusion pressure, tissue glucose, lactate, pyruvate, glycerol, glutamate, cytokines measured from the injury site

    Measured: Up to 5 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2021
  2. Study start8 Oct 2021
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase III clinical trial: randomised, controlled, double blind, multi-centre, superiority \+ Optional mechanistic study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
222 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04936620
Sponsor's protocol ID
2021.0056
Other IDs
25573423
Acronym
DISCUS
Status last verified
Jul 2026
First submitted
21 Jun 2021
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Appropriately anonymised datasets from our sponsored research will be made available for further analysis wherever possible under our Research Data Management policy: https://www.sgul.ac.uk/about/governance/policies/research-data-management

Publications

  • Saadoun S, Asif H, Papadopoulos MC. The concepts of Intra Spinal Pressure (ISP), Intra Thecal Pressure (ITP), and Spinal Cord Perfusion Pressure (SCPP) in acute, severe traumatic spinal cord injury: Narrative review. Brain Spine. 2024 Oct 16;4:103919. doi: 10.1016/j.bas.2024.103919. eCollection 2024.

    PubMed 39654909

  • Saadoun S, Grassner L, Belci M, Cook J, Knight R, Davies L, Asif H, Visagan R, Gallagher MJ, Thome C, Hutchinson PJ, Zoumprouli A, Wade J, Farrar N, Papadopoulos MC. Duroplasty for injured cervical spinal cord with uncontrolled swelling: protocol of the DISCUS randomized controlled trial. Trials. 2023 Aug 7;24(1):497. doi: 10.1186/s13063-023-07454-2.

    PubMed 37550727

  • Werndle MC, Saadoun S, Phang I, Czosnyka M, Varsos GV, Czosnyka ZH, Smielewski P, Jamous A, Bell BA, Zoumprouli A, Papadopoulos MC. Monitoring of spinal cord perfusion pressure in acute spinal cord injury: initial findings of the injured spinal cord pressure evaluation study*. Crit Care Med. 2014 Mar;42(3):646-55. doi: 10.1097/CCM.0000000000000028.

    PubMed 24231762

  • Phang I, Werndle MC, Saadoun S, Varsos G, Czosnyka M, Zoumprouli A, Papadopoulos MC. Expansion duroplasty improves intraspinal pressure, spinal cord perfusion pressure, and vascular pressure reactivity index in patients with traumatic spinal cord injury: injured spinal cord pressure evaluation study. J Neurotrauma. 2015 Jun 15;32(12):865-74. doi: 10.1089/neu.2014.3668. Epub 2015 May 4.

    PubMed 25705999

  • Phang I, Zoumprouli A, Papadopoulos MC, Saadoun S. Microdialysis to Optimize Cord Perfusion and Drug Delivery in Spinal Cord Injury. Ann Neurol. 2016 Oct;80(4):522-31. doi: 10.1002/ana.24750. Epub 2016 Aug 19.

    PubMed 27463064

  • Saadoun S, Papadopoulos MC. Acute, Severe Traumatic Spinal Cord Injury: Monitoring from the Injury Site and Expansion Duraplasty. Neurosurg Clin N Am. 2021 Jul;32(3):365-376. doi: 10.1016/j.nec.2021.03.008. Epub 2021 May 7.

    PubMed 34053724

  • Asif H, Tsan SEH, Boseta E, Zoumprouli A, Papadopoulos MC, Saadoun S. Effect of Sevoflurane Concentration, Blood Pressure, Arterial Carbon Dioxide Tension, Temperature, and Stimulation on Spinal Cord Blood Flow in Patients Undergoing Spinal Surgery: An Exploratory Study. Anesthesiology. 2026 Apr 1;144(4):1012-1015. doi: 10.1097/ALN.0000000000005911. Epub 2026 Jan 30. No abstract available.

    PubMed 41619740

Questions about this trial

What is this clinical trial studying?

A study testing Duroplasty and Spinal surgery in people with Spinal Cord Injuries, run by St George's, University of London at 34 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United Kingdom, Austria, Germany, Israel, Belgium and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sophie Reynolds (079 17100953, discus@nds.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in AIS motor score (time frame: 6 months versus baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04936620, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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