Spinal cord injury (SCI) Injury, Occupational Diseases, Poisoning Injury of nerves and spinal cord at thorax level
Conditions
Interventions
Surgical decompression of compressed spinal cord and stabilisation. This intervention is performed in both groups of early and so called late decompression. Because surgical technique varies according
Sponsors
Sina Trauma and Surgery Research Centre (Iran)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, 18 years or older 2. Spinal cord injury between T1 and L1 of traumatic etiology 3. Haemodynamically stable 4. Spinal cord compression on magnetic resonance imaging (MRI) 5. Between 0 hours and 24 hours post-injury
Exclusion criteria
Exclusion criteria: 1. Subjects with major and current psychiatric illness 2. Significant traumatic brain injury associated with the spinal cord injury 3. Major concurrent medical disease (including myocardial infarction within 3 months, uncompensated congestive heart failure, active systemic cancer, acquired immune deficiency syndrome [AIDS], diabetes mellitus) 4. Pre-injury major neurologic deficits or disease (e.g., stroke, Parkinson's disease, syringomyelia, Guilian-Barre) 5. Ankylosing spondylitis 6. Penetrating injuries to the thoracolumbar 7. Pregnant females 8. Life-threatening injuries which prevent early decompression of the spinal cord 9. Criminals 10. Under indictment or incarceration 11. Substance abuse 12. American Spinal Injury Association (ASIA) Impairment Scale category of E 13. No cord compression on MRI 14. Presence of spinal shock 15. Any cognitive deficit 16. Unable to provide informed consent 17. An injury which involves more than two adjacent vertebral levels Selected participants are thoroughly informed of the trial and its attendant risks and asked to consent to be in one of two groups, those operated urgently in less than 24 hours from trauma or the late group who are operated and decompressed between 24 and 72 hours from trauma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether early or late surgical decompression is effective in neurological improvement in the setting of traumatic spinal cord injury from T1 to L1, assessed at all clinical assessment timepoints. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the neurological improvement in summed ASIA motor scores 12 months following a complete SCI in each of the early and late group of decompression 2. To compare the neurological improvement in summed ASIA motor scores 12 months following an incomplete SCI in each of the early and late group of decompression 3. To assess the extent of neural canal decompression in each of the early and late group of decompression 4. To assess fusion success in each of the early and late group of decompression 5. To assess sagittal alignment at fracture level in each of the early and late group of decompression 6. To compare the duration of acute hospitalization in each of the early and late group of decompression 7. To compare the overall length of acute hospital stay in each of the early and late decompression 8. To compare the overall length of chronic hospital stay for rehabilitation [22] in each of the early and late decompression 9. To assess the incidence of mortality in each of the early and late group of decompression 10. To determine frequency of complications in each of the early and late group of decompression Timepoints of assessment: 1. First clinical assessment: At the time of admission 2. Second clinical assessment: In the last hour before operation 3. Third clinical assessment: Immediately after operation and awakening from anaesthesia 4. Fourth clinical assessment: Six weeks after operation 5. Fifth clinical assessment: Six months after operation 6. Sixth clinical assessment: 12 months after operation 7. Seventh clinical assessment: The most recent follow-up Imaging check up: First: Before operation Second: Within a maximum of 7 days after | — |
Countries
Iran
Outcome results
None listed