The role of early surgery in patients paralysed following injury

ISRCTN	ISRCTN61263382
DOI	https://doi.org/10.1186/ISRCTN61263382
Secondary identifying numbers	N/A

Submission date: 06/05/2009
Registration date: 28/05/2009
Last edited: 28/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Vafa Rahimi-Movaghar
Scientific

Research Centre for Neural Repair
Sina Trauma and Surgery Research Centre
Sina Hospital
Hassan-Abad Square
Imam Khomeini Ave
Tehran University of Medical Sciences
Tehran
11365-3876
Iran

Phone	+98 915 342 2682
Email	v_rahimi@sina.tums.ac.ir

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	24.72HSCITL
Study objectives	The role and timing of surgical decompression after an acute spinal cord injury (SCI) remains one of the most controversial topics pertaining to spinal surgery. Blunt spinal trauma complicated by injury to the spinal cord most frequently occurs in the young male patient. The lack of controlled, prospective, multicenter clinical studies has contributed to confusion regarding optimal treatment methods for patients with injuries to the spinal cord. The spinal cord is vulnerable to injury resulting from high-energy motor vehicle collisions and falls. Regarding location of spinal cord, cervical and thoracolumbar area can be selected. This RCT tries to evaluate the thoracolumbar cord which we evaluated this area in previous retrospective studies. Thus, we chose patients with acute spinal cord injury from T1 to L1. Hypothesis: first 24 hours surgical decompression is more effective than 24-72 hours in neurological improvement in the setting of traumatic spinal cord injury from T1 to L1.
Ethics approval(s)	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)
Health condition(s) or problem(s) studied	Spinal cord injury (SCI)
Intervention	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.
Intervention type	Other
Primary outcome measure	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 measures	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.
Overall study start date	22/05/2009
Completion date	21/05/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	328
Total final enrolment	73
Key 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
Key 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.
Date of first enrolment	22/05/2009
Date of final enrolment	21/05/2013

Locations

Countries of recruitment

Iran

Study participating centre

Research Centre for Neural Repair

Tehran
11365-3876
Iran

Sponsor information

Sina Trauma and Surgery Research Centre (Iran)
University/education

Sina Hospital
Hassan-Abad Square
Imam Khomeini Ave
Tehran University of Medical Sciences
Tehran
11365-3876
Iran

Phone	+98 216 670 5140
Email	sintrc_head@sina.tums.ac.ir
Website	http://www.sinatrc.ac.ir/
"ROR"	https://ror.org/01jqdqz10

Funders

Funder type

University/education

Sina Trauma and Surgery Research Centre, Tehran University of Medical Sciences (Iran) (Grant number: 76) (date confirmed: 3rd June 2008)

No information available

Shahid Beheshti University of Medical Sciences (Iran) (Grant number: 400/6691) (date confirmed: 18th January 2009)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	24/08/2009		Yes	No
Results article		18/09/2020	28/10/2022	Yes	No

Editorial Notes

28/10/2022: Publication reference and total final enrolment added.