NCT04936620

Brief 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. 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? We will recruit patients from U.K. Major Trauma Centres. Most assessments will be done in U.K. Spinal Injury Centres. Later on, we may recruit 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.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
12 countries

33 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Oct 2021Jun 2028

First Submitted

Initial submission to the registry

June 21, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

October 8, 2021

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

6.7 years

First QC Date

June 21, 2021

Last Update Submit

January 26, 2026

Conditions

Spinal Cord Injuries

Keywords

Decompression, surgical; Neurosurgery; Paralysis

Outcome Measures

Primary Outcomes (1)

  • Change in AIS motor score

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

    6 months versus baseline

Secondary Outcomes (14)

  • Change in AIS light touch score

    6 months versus baseline

  • Change in AIS pin prick score

    6 months versus baseline

  • Change in AIS grade

    6 months versus baseline

  • CUE-Q

    6 months

  • Grip strength

    6 months

  • +9 more secondary outcomes

Study Arms (2)

Duroplasty

ACTIVE COMPARATOR

Duroplasty (includes Surgery with Laminectomy)

Procedure: DuroplastyProcedure: Spinal surgery

No duroplasty

ACTIVE COMPARATOR

No duroplasty (but includes surgery with Laminectomy)

Procedure: Spinal surgery

Interventions

DuroplastyPROCEDURE

Expansion Duroplasty

Duroplasty
Spinal surgeryPROCEDURE

Spinal surgery including laminectomy

DuroplastyNo duroplasty

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Universität Klinik für Neurochirurgie

Innsbruck, Austria

RECRUITING

Kepler University Hospital

Linz, Austria

RECRUITING

University Hospital Salzburg

Salzburg, Austria

RECRUITING

St Polten University Hospital

Sankt Pölten, Austria

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

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

Wuhan, Hubei, China

RECRUITING

Masaryk Hospital

Ústí nad Labem, Czechia

RECRUITING

Aarhus University Hospital

Aarhus, Denmark

RECRUITING

Kuopio University Hospital

Kuopio, Finland

RECRUITING

BG Unfallklinik Frankfurt am Main

Frankfurt, Germany

RECRUITING

Hadassah Medical Center

Jerusalem, Israel

RECRUITING

Shaare Zedek Medical Centre

Jerusalem, Israel

RECRUITING

University Medical Centre Ljubljana

Ljubljana, Slovenia

RECRUITING

12 de Octubre University Hospital

Madrid, Spain

RECRUITING

Skåne University Hospital

Lund, Sweden

RECRUITING

National Spinal Injuries Centre

Aylesbury, United Kingdom

ACTIVE NOT RECRUITING

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

RECRUITING

Addenbrooke's Hospital

Cambridge, United Kingdom

RECRUITING

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

RECRUITING

Queen Elizabeth University Hospital

Glasgow, United Kingdom

RECRUITING

Hull Royal Infirmary

Hull, United Kingdom

RECRUITING

Leeds General Infirmary

Leeds, United Kingdom

RECRUITING

The Walton Centre

Liverpool, United Kingdom

RECRUITING

St George's Hospital

London, United Kingdom

RECRUITING

St Mary's Hospital

London, United Kingdom

RECRUITING

The London Spinal Cord Injury Centre

London, United Kingdom

ACTIVE NOT RECRUITING

The Royal London Hospital

London, United Kingdom

RECRUITING

Queen's Medical Centre

Nottingham, United Kingdom

RECRUITING

Midlands Centre for Spinal Injuries,

Oswestry, United Kingdom

ACTIVE NOT RECRUITING

Salford Royal

Salford, United Kingdom

RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

RECRUITING

North West Regional Spinal Injuries Centre

Southport, United Kingdom

ACTIVE NOT RECRUITING

Pinderfields Hospital

Wakefield, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (7)

  • 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.

    PMID: 39654909BACKGROUND

  • 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.

    PMID: 37550727BACKGROUND

  • 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.

    PMID: 24231762BACKGROUND

  • 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.

    PMID: 25705999BACKGROUND

  • 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.

    PMID: 27463064BACKGROUND

  • 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.

    PMID: 34053724BACKGROUND

  • 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.

    PMID: 41619740DERIVED

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesParalysis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marios C Papadopoulos

    St George's, University of London, U.K.

    PRINCIPAL INVESTIGATOR

  • Samira Saadoun

    St George's, University of London, U.K.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Reynolds

CONTACT

079 17100953discus@nds.ox.ac.uk

Ghazal Ebrat

CONTACT

gebrat@sgul.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants, some care providers (ie: physiotherapists) and outcome assessor will be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Phase III clinical trial: randomised, controlled, double blind, multi-centre, superiority \+ Optional mechanistic study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2021

First Posted

June 23, 2021

Study Start

October 8, 2021

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Publications on this study will be available form PubMed, Study website and other publicly accessible resources.
Access Criteria
Specific requests for data sharing should be directed to sponsor St George's University London.
More information

Locations

AU(4)ES(1)SL(1)GB(18)CZ(1)DE(1)BE(1)SE(1)FI(1)CN(1)DK(1)IL(2)