Condition: Spinal Cord Injuries · Sponsor: St George's, University of London
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 recruitin…
This description comes directly from the study's public registry record.
Sophie Reynolds · 079 17100953 · discus@nds.ox.ac.uk
Ghazal Ebrat · gebrat@sgul.ac.uk
Always discuss trial participation with your own doctor first.
| 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 |
| Klinik und Poliklinik für Neurochirurgie Universitätsklinikum Frankfurt, 60596 FRANKFURT AM MAIN | Frankfurt, Germany | Recruiting |
| Hadassah Medical Center | Jerusalem, Israel | Recruiting |
+ 22 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04936620