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Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling

RecruitingNAAges 16 Years - anyAllSt George's, University of London
NCT04936620 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 r

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥16 years 2. Severe cervical (C2 - T1) traumatic spinal cord injury (AIS grade A-C) 3. Deemed to require and be suitable for surgery that includes laminectomy by local surgeon 4. Surgery within 72 hours of traumatic spinal cord injury 5. Able to provide informed consent or consultee declaration or proxy consent. Exclusion Criteria: 1. Dural tear due to traumatic spinal cord injury 2. Life-limiting or rehabilitation-restricting co-morbidities 3. Thoracic or lumbar traumatic spinal cord injury 4. Other central nervous system disease
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What it tests

  • Duroplasty
  • Spinal surgery
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Where

34 sites
Universität Klinik für Neurochirurgie
Innsbruck, Austria
Kepler University Hospital
Linz, Austria
University Hospital Salzburg
Salzburg, Austria
St Polten University Hospital
Sankt Pölten, Austria
UZ Leuven
Leuven, Belgium
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Masaryk Hospital
Ústí nad Labem, Czechia
Aarhus University Hospital
Aarhus, Denmark

…and 26 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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