An interventional study of Duroplasty and Spinal surgery in Spinal Cord Injuries, sponsored by St George's, University of London. Recruiting at 34 sites in 12 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by St George's, University of London · Not applicable, Interventional, and Treatment
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? 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.
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).
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 222 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →St George's, University of London is the lead sponsor of 106 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Duroplasty (includes Surgery with Laminectomy)
Procedure: Duroplasty · Procedure: Spinal surgery
No duroplasty (but includes surgery with Laminectomy)
Procedure: Spinal surgery
Expansion Duroplasty
Spinal surgery including laminectomy
Change in AIS motor score
Change in American Spinal Injury Association Impairment Scale total limb motor score at 6 months
Time frame: 6 months versus baseline
Change in AIS light touch score
Change in American Spinal Injury Association Impairment Scale total light touch sensory score
Time frame: 6 months versus baseline
Change in AIS pin prick score
Change in American Spinal Injury Association Impairment Scale total pin prick sensory score
Time frame: 6 months versus baseline
Change in AIS grade
Change in American Spinal Injury Association grade
Time frame: 6 months versus baseline
CUE-Q
Capabilities of upper extremity-questionnaire (CUE-Q)
Time frame: 6 months
Grip strength
Hand grip strength assessed with dynamometer
Time frame: 6 months
WISCI II
Walking Index for Spinal Cord Injury version ii
Time frame: 6 months
SCIM III
Spinal Cord Independence Measure version III
Time frame: 6 months
SF-36
Short Form survey 36
Time frame: 6 months, 12 months
Spinal re-operations
Number of reoperations on spine
Time frame: 12 months
Adverse events
Procedure Specific complications and adverse events
Time frame: 12 months
Mortality
Mortality
Time frame: 12 months
Length of hospital stay
Length of hospital stay
Time frame: 12 months
MRI
Magnetic resonance imaging of cervical spine
Time frame: 2 weeks, 6 months
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
Time frame: Up to 5 days after surgery
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PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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
Supporting information: Study protocol, Clinical study report
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.
Data sharing details ↗ · www.sgul.ac.uk
Started Oct 2021 (actual). Primary completion is estimated for Jun 2028, 80 months after the start.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 80 months is above that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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