Traumatic Spinal Cord Injury (TSCI) Nervous System Diseases Injury of nerves and spinal cord at neck level
Conditions
Interventions
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/
Sponsors
St George's, University of London
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion 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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional impairment measured using the American Spinal Injury Association Impairment Scale total limb motor score at baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase III trial: 1. Light-touch sensory impairment measured using the American Spinal Injury Association Impairment Scale total light touch sensory score at baseline and 6 months 2. Pin prick sensory impairment measured using the American Spinal Injury Association Impairment Scale total pin prick sensory scoreat baseline and 6 months 3. Functional impairment in American Spinal Injury Association grade at baseline and 6 months 4. Upper extremity function measured using the Capabilities of Upper Extremity-Questionnaire (CUE-Q) at 6 months 5. Hand grip strength measured using a dynamometer at 6 months 6. Walking ability measured using Walking Index for Spinal Cord Injury version ii (WISCI II) at 6 months 7. Independence in activities of daily living measured using Spinal Cord Independence Measure version iii (SCIM III) at 6 months 8. Health status measured using the Short Form survey (SF-36) at 3, 6, and 12 months 9. Number of reoperations on spine measured from patient records at 12 months 10. Procedure Specific complications and adverse events measured from patient records at 12 months 11. Mortality measured from patient records at 12 months 12. Length of hospital stay measured from patient records at 12 months 13. Spinal deformity (Cobb angle), length of tethered cord, and size of syrinx measured using magnetic resonance imaging (MRI) at 6 months Optional mechanistic study: 1. Mean daily intraspinal pressure measured using a pressure probe at the injury site for up to 5 days after surgery 2. Spinal cord perfusion pressure measured using a pressure probe at the injury site for up to 5 days after surgery 3. Tissue glucose, lactate, pyruvate, glycerol, glutamate, and cytokines measured using an intradural microdialysis catheter at the injury site for up to 5 days after surgery | — |
Countries
Austria, Belgium, China, Czech Republic, Denmark, England, Finland, Germany, Israel, Northern Ireland, Scotland, Slovenia, Spain, Sweden, United Kingdom
Contacts
Public ContactSophie;Sophie Reynolds;Reynolds
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Outcome results
None listed