NCT04936620 Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling
| NCT ID | NCT04936620 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St George's, University of London |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 222 participants |
| Start Date | 2021-10-08 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 222 participants in total. It began in 2021-10-08 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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? 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.
Eligibility Criteria
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
Contact & Investigator
Marios C Papadopoulos
PRINCIPAL INVESTIGATOR
St George's, University of London, U.K.
Frequently Asked Questions
Who can join the NCT04936620 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04936620 currently recruiting?
Yes, NCT04936620 is actively recruiting participants. Contact the research team at discus@nds.ox.ac.uk for enrollment information.
Where is the NCT04936620 trial being conducted?
This trial is being conducted at Innsbruck, Austria, Linz, Austria, Salzburg, Austria, Sankt Pölten, Austria and 11 additional locations.
Who is sponsoring the NCT04936620 clinical trial?
NCT04936620 is sponsored by St George's, University of London. The principal investigator is Marios C Papadopoulos at St George's, University of London, U.K.. The trial plans to enroll 222 participants.