Duroplasty for Injured cervical Spinal Cord with Uncontrolled Swelling (DISCUS)
Traumatic Spinal Cord Injury (TSCI)
Randomised trial: The control arm is surgery including laminectomy. The intervention arm is surgery including laminectomy and duroplasty. Duroplasty takes 10-15 min during the operation. The control/intervention surgeries will be done within 72 h of injury. Mechanistic study: Insertion of pressure probe and/or microdialysis catheter intradurally at the injury site. This is optional and is done during the surgical procedure. The probes are left in for a maximum of 5 days. All patients will be followed up for 6 months and 1 year after randomisation. Patients will be randomised 1:1 to one of the two trial arms. The allocation to treatment options will use a web based secure randomisation system (RRAMP) using minimisation algorithm (age and country).
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 h of traumatic spinal cord injury (TSCI) 5. Able to provide informed consent or proxy consent or consent/declaration provided by consultee, nearest relative/guardian/welfare attorney
1. Dural tear due to traumatic spinal cord injury (TSCI) 2. Life-limiting or rehabilitation-restricting co-morbidities 3. Thoracic or lumbar traumatic spinal cord injury 4. Other central nervous system disease