The role of early surgery in patients paralysed following injury

Not Applicable

Completed

• Conditions: Spinal cord injury (SCI); Injury, Occupational Diseases, Poisoning; Injury of nerves and spinal cord at thorax level

• Registration Number: ISRCTN61263382
• Lead Sponsor: Sina Trauma and Surgery Research Centre (Iran)

Brief Summary

2009 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/19703282 protocol 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/34223533/ (added 28/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-28
• Study Completion: 2013-05-21
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 73

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified