The role of early surgery in patients paralysed following injury

• Register: ISRCTN
• Last refreshed on: 7 November 2022
• Main ID: ISRCTN61263382
• Date of registration: 28/05/2009
• Prospective Registration: No
• Primary sponsor: Sina Trauma and Surgery Research Centre (Iran)
• Public title: The role of early surgery in patients paralysed following injury
• Scientific title: The efficacy of surgical decompression before 24 hours versus 24 to 72 hours in patients with spinal cord injury from T1 to L1 - with specific consideration on ethics: a randomised controlled trial
• Date of first enrolment: 22/05/2009
• Target sample size: 328
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN61263382
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Iran

Contacts

• Name: Vafa Rahimi-Movaghar

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 to the location of injury in the spine and the nature of the injury, surgeons are not restricted in their surgical technique.

Primary Outcome(s)

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 Outcome(s)

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 operation
Third: 12 months after operation

Each of the other secondary outcome measures is evaluated at least twice: first before operation and 12 months after operation.

Secondary ID(s)

N/A

Source(s) of Monetary Support

Sina Trauma and Surgery Research Centre, Tehran University of Medical Sciences (Iran) (Grant number: 76) (date confirmed: 3rd June 2008), Shahid Beheshti University of Medical Sciences (Iran) (Grant number: 400/6691) (date confirmed: 18th January 2009)

Ethics review

Status:
Approval date:
Contact:

1. Ethics Committee of the Sina Trauma and Surgery Research Centre, Tehran University of Medical Sciences, approved on the 3rd June 2008 (ref: 15) 2. Ethics Committee of the Shahid Beheshti University of Medical Sciences, approved on the 28th October 2007 (ref: 44)

Results

• Results available: Yes
• Date Completed: 21/05/2013