Spinal Cord InjuryNCT06717503
Medico-legality of Acute Spinal Cord Injuries
An observational study of Spinal Cord Injury, run by Assiut University.
Trial summary
1. Describe different medico-legal aspects of TSI (mode of trauma, cause and Pattern of spinal injuries). 2. Assess the outcome of TSI in studied cases. 3. Associate type of trauma with the different patterns of acute spinal injuries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- data collection
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: A structured data sheet is prepared and included the following: (A)Patients' demographic and epidemiological data such as age, sex, residence, education and marital state. (B)Mode of trauma (accidental, homicidal, suicidal). (C)Cause of injury like motor car, motor cycle accident, fall from height, blunt trauma, sports, occupation….etc. (D)Method of arrival to hospital. (E)Time passed between trauma and arrival at hospital. (F)How to deal with the TSI patients from the time of the injury until arrival at hospital. (G)Examination findings, including careful documentation of the neurological status. (H)Imaging findings, including plain X-rays, MSCT, and MRI. (I)Type and level of the injury (fracture, dislocation, ligament tear, associated bone injuries…etc). (J)Sequels (deformity, disability, permanent infirmity and death). (K)Hospital stay period and operations
Who may be able to join
- All patients presenting with acute TSI regardless level of injury, or neurological status.
Who cannot join
- Patients have congenital anomalies, neurological defects or disability before trauma.
- Patients with pathological spinal cord diseases were excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Medico-legal Aspects of Acute Spinal Injuries at Trauma Unit of Assiut University Hospital
- Describe different medico-legal aspects of TSI (mode of trauma, cause and Pattern of spinal injuries).
- Assess the outcome of TSI in studied cases.
- Associate type of trauma with the different patterns of acute spinal injuries.
Read the detailed description
A medico-legal case (MLC) applies to any case of injury or medical condition in which law enforcement agencies seek to investigate and fix the responsibility regarding the said injury or medical condition. From a physician's perspective, a MLC is a medical or clinical case with legal implications. In such cases presented directly to the hospital, after obtaining a detailed history and examination of the patient, the physician concludes the need for the law enforcement administration to investigate further. Besides, such cases could also be referred to the physician by the law enforcement administration for application of medical expertise and opinion to aid in the administration of justice .
Trauma is the 6th leading cause of death worldwide resulting in 5 million of all deaths. It is the 5th leading cause of significant disability . In Egypt, injuries the fifth leading cause of death and the most common cause of hospitalization and account for at least 1/4 of all inpatient(World Health Organization 2009). Spine is one of the body parts that is commonly subjected to trauma . Traumatic spinal injuries as seen from a medico-legal point of view, is an integral part of medical practice in emergency department..
SCI is associated with permanent disability and decreased life expectancy .Although more than 80% of the world's population live in the more than 100 developing countries, little information is available regarding the epidemiology of SCI in these countries . The higher prevalence of TSI may be due to the increased frequency of events causing injury, such as road traffic accidents (RTAs), and higher rates of occupational-related incidents, such as falls from trees .
Permanent infirmity is a major sequel of spinal fractures, it is considered as a legal as well as a medical problem. Physician should be oriented about the legal issues of compensation to help them in saving patients' rights . The cervical spinal cord is the most commonly affected level, followed by the thoracic and lumbar . Lower thoracic lesions can cause paraplegia while lesions at cervical level are associated with quadriplegia.
Concerning the mechanisms of injury, they differ in different age groups: common causes are road accidents, followed by traumas caused by falls, attacks, sports, or occupational-related Incidents . Imaging investigations showing different types of spinal cord injuries including fracture, dislocation, damage to the intervertebral discs, ligament tear, vascular affection, and associated injures . TSI occurs more frequently and has worse outcomes in low and middle-income countries than in high-income countries .
The number of disabled has increased considerably. The development constitutes a good reason for paying more specific attention to society's growing number of disabled. To our knowledge, up to 2024 there is a deficient studies in medico-legal aspect of traumatic spinal injuries and its squeals in Upper Egypt.
- Conditions
- Spinal Cord Injury
- Being tested
- data collection
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
data will be collected from data sheets of acute spinal cord injury patients (Patients' demographic and epidemiological ,Mode of trauma, Cause of injury, Method of arrival to hospital, Time passed between trauma and arrival at hospital,How to deal with the TSI patients from the time of the injury until arrival at hospital, Examination findings, Imaging findings, Type and level of the injury, Sequels, Hospital stay period and operations)
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of medico-legal aspects of traumatic spinal injury cases includind 1 mode of trauma: suicidal, homicidal or accidental 2 causes :road traffic injuries, fall from height, assault from other...etc 3 Pattern: type and level of the injury.
A structured data sheet is prepared and included the following:
(A)Patients' demographic and epidemiological data such as age, sex, residence, education and marital state.
(B)Mode of trauma (accidental, homicidal, suicidal). (C)Cause of injury like motor car, motor cycle accident, fall from height, blunt trauma, sports, occupation….etc.
(G)Examination findings, including careful documentation of the neurological status.
(H)Imaging findings, including plain X-rays, MSCT, and MRI. (I)Type and level of the injury (fracture, dislocation, ligament tear, associated bone injuries…etc).
(J)Sequels (deformity, disability, permanent infirmity and death). this data will be collected from the patients and analysis to data
Measured: baseline
Secondary outcomes (1)
Determine the association between causes of trauma( motor car, motor cycle accident, fall from height, blunt trauma, sports, occupation….etc) with the different patterns of acute spinal injuries including type and level from imaging investigation.
after analysis of data we will make a correlation between the data like Determine the association between causes of trauma( motor car, motor cycle accident, fall from height, blunt trauma, sports, occupation….etc) with the different patterns of acute spinal injuries including type :fracture or dislocation and level :cervical or lumber from imaging investigation .
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Khalid Mohamed Ismail, Assiut University
- Investigators
- Doaa Mohamed Abd El Rahman, Assistant Professor, Study director, Doaa Mohamed Abd El RahmanAli Mohamedein Mohamed, professor, Study director, Ali Mohamedein Mohamed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717503
- Sponsor's protocol ID
- Acute spinal cord injuries
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilson JR, Cadotte DW, Fehlings MG. Clinical predictors of neurological outcome, functional status, and survival after traumatic spinal cord injury: a systematic review. J Neurosurg Spine. 2012 Sep;17(1 Suppl):11-26. doi: 10.3171/2012.4.AOSPINE1245.
PubMed 22985366Vazquez XM, Rodriguez MS, Penaranda JM, Concheiro L, Barus JI. Determining prognosis after spinal cord injury. J Forensic Leg Med. 2008 Jan;15(1):20-3. doi: 10.1016/j.jflm.2007.06.003. Epub 2007 Sep 25.
PubMed 18096510Singh A, Tetreault L, Kalsi-Ryan S, Nouri A, Fehlings MG. Global prevalence and incidence of traumatic spinal cord injury. Clin Epidemiol. 2014 Sep 23;6:309-31. doi: 10.2147/CLEP.S68889. eCollection 2014.
PubMed 25278785Soreide K. Epidemiology of major trauma. Br J Surg. 2009 Jul;96(7):697-8. doi: 10.1002/bjs.6643. No abstract available.
PubMed 19526611Kumar R, Lim J, Mekary RA, Rattani A, Dewan MC, Sharif SY, Osorio-Fonseca E, Park KB. Traumatic Spinal Injury: Global Epidemiology and Worldwide Volume. World Neurosurg. 2018 May;113:e345-e363. doi: 10.1016/j.wneu.2018.02.033. Epub 2018 Feb 14.
PubMed 29454115Blackmore CC, Emerson SS, Mann FA, Koepsell TD. Cervical spine imaging in patients with trauma: determination of fracture risk to optimize use. Radiology. 1999 Jun;211(3):759-65. doi: 10.1148/radiology.211.3.r99jn22759.
PubMed 10352603Aktas N, Gulacti U, Lok U, Aydin I, Borta T, Celik M. Characteristics of the Traumatic Forensic Cases Admitted To Emergency Department and Errors in the Forensic Report Writing. Bull Emerg Trauma. 2018 Jan;6(1):64-70. doi: 10.29252/beat-060110.
PubMed 29379812
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-legal Aspects of Acute Spinal Injuries at Trauma Unit of Assiut University Hospital
- ClinicalTrials.gov ID
- NCT06717503
- Acronym / sponsor ID
- Acute spinal cord injuries
- Conditions
- Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Describe different medico-legal aspects of TSI (mode of trauma, cause and Pattern of spinal injuries).
- Assess the outcome of TSI in studied cases.
- Associate type of trauma with the different patterns of acute spinal injuries.
Detailed description
A medico-legal case (MLC) applies to any case of injury or medical condition in which law enforcement agencies seek to investigate and fix the responsibility regarding the said injury or medical condition. From a physician's perspective, a MLC is a medical or clinical case with legal implications. In such cases presented directly to the hospital, after obtaining a detailed history and examination of the patient, the physician concludes the need for the law enforcement administration to investigate further. Besides, such cases could also be referred to the physician by the law enforcement administration for application of medical expertise and opinion to aid in the administration of justice .
Trauma is the 6th leading cause of death worldwide resulting in 5 million of all deaths. It is the 5th leading cause of significant disability . In Egypt, injuries the fifth leading cause of death and the most common cause of hospitalization and account for at least 1/4 of all inpatient(World Health Organization 2009). Spine is one of the body parts that is commonly subjected to trauma . Traumatic spinal injuries as seen from a medico-legal point of view, is an integral part of medical practice in emergency department..
SCI is associated with permanent disability and decreased life expectancy .Although more than 80% of the world's population live in the more than 100 developing countries, little information is available regarding the epidemiology of SCI in these countries . The higher prevalence of TSI may be due to the increased frequency of events causing injury, such as road traffic accidents (RTAs), and higher rates of occupational-related incidents, such as falls from trees .
Permanent infirmity is a major sequel of spinal fractures, it is considered as a legal as well as a medical problem. Physician should be oriented about the legal issues of compensation to help them in saving patients' rights . The cervical spinal cord is the most commonly affected level, followed by the thoracic and lumbar . Lower thoracic lesions can cause paraplegia while lesions at cervical level are associated with quadriplegia.
Concerning the mechanisms of injury, they differ in different age groups: common causes are road accidents, followed by traumas caused by falls, attacks, sports, or occupational-related Incidents . Imaging investigations showing different types of spinal cord injuries including fracture, dislocation, damage to the intervertebral discs, ligament tear, vascular affection, and associated injures . TSI occurs more frequently and has worse outcomes in low and middle-income countries than in high-income countries .
The number of disabled has increased considerably. The development constitutes a good reason for paying more specific attention to society's growing number of disabled. To our knowledge, up to 2024 there is a deficient studies in medico-legal aspect of traumatic spinal injuries and its squeals in Upper Egypt.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- A structured data sheet is prepared and included the following: (A)Patients' demographic and epidemiological data such as age, sex, residence, education and marital state. (B)Mode of trauma (accidental, homicidal, suicidal). (C)Cause of injury like motor car, motor cycle accident, fall from height, blunt trauma, sports, occupation….etc. (D)Method of arrival to hospital. (E)Time passed between trauma and arrival at hospital. (F)How to deal with the TSI patients from the time of the injury until arrival at hospital. (G)Examination findings, including careful documentation of the neurological status. (H)Imaging findings, including plain X-rays, MSCT, and MRI. (I)Type and level of the injury (fracture, dislocation, ligament tear, associated bone injuries…etc). (J)Sequels (deformity, disability, permanent infirmity and death). (K)Hospital stay period and operations
Key inclusion criteria (1 listed)
- All patients presenting with acute TSI regardless level of injury, or neurological status.
Key exclusion criteria (2 listed)
- Patients have congenital anomalies, neurological defects or disability before trauma.
- Patients with pathological spinal cord diseases were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectiondata will be collected from data sheets of acute spinal cord injury patients (Patients' demographic and epidemiological ,Mode of trauma, Cause of injury, Method of arrival to hospital, Time passed between trauma and arrival at hospital,How to deal with the TSI patients from the time of the injury until arrival at hospital, Examination findings, Imaging findings, Type and level of the injury, Sequels, Hospital stay period and operations) | Other | – |
Primary outcome
Evaluation of medico-legal aspects of traumatic spinal injury cases includind 1 mode of trauma: suicidal, homicidal or accidental 2 causes :road traffic injuries, fall from height, assault from other...etc 3 Pattern: type and level of the injury.
Time frame: baseline
A structured data sheet is prepared and included the following: (A)Patients' demographic and epidemiological data such as age, sex, residence, education and marital state. (B)Mode of trauma (accidental, homicidal, suicidal). (C)Cause of injury like motor car, motor cycle accident, fall from height, blunt trauma, sports, occupation….etc. (G)Examination findings, including careful documentation of the neurological status. (H)Imaging findings, including plain X-rays, MSCT, and MRI. (I)Type and level of the injury (fracture, dislocation, ligament tear, associated bone injuries…etc). (J)Sequels (deformity, disability, permanent infirmity and death). this data will be collected from the patients and analysis to data
1 secondary outcome
Determine the association between causes of trauma( motor car, motor cycle accident, fall from height, blunt trauma, sports, occupation….etc) with the different patterns of acute spinal injuries including type and level from imaging investigation.
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Results publication: PubMed 22985366Wilson JR, Cadotte DW, Fehlings MG. Clinical predictors of neurological outcome, functional status, and survival after traumatic spinal cord injury: a systematic review. J Neurosurg Spine. 2012 Sep;17(1 Suppl):11-26. doi: 10.3171/2012.4.AOSPINE1245.
- Results publication: PubMed 18096510Vazquez XM, Rodriguez MS, Penaranda JM, Concheiro L, Barus JI. Determining prognosis after spinal cord injury. J Forensic Leg Med. 2008 Jan;15(1):20-3. doi: 10.1016/j.jflm.2007.06.003. Epub 2007 Sep 25.
- Results publication: PubMed 25278785Singh A, Tetreault L, Kalsi-Ryan S, Nouri A, Fehlings MG. Global prevalence and incidence of traumatic spinal cord injury. Clin Epidemiol. 2014 Sep 23;6:309-31. doi: 10.2147/CLEP.S68889. eCollection 2014.
- Results publication: PubMed 19526611Soreide K. Epidemiology of major trauma. Br J Surg. 2009 Jul;96(7):697-8. doi: 10.1002/bjs.6643. No abstract available.
- Results publication: PubMed 29454115Kumar R, Lim J, Mekary RA, Rattani A, Dewan MC, Sharif SY, Osorio-Fonseca E, Park KB. Traumatic Spinal Injury: Global Epidemiology and Worldwide Volume. World Neurosurg. 2018 May;113:e345-e363. doi: 10.1016/j.wneu.2018.02.033. Epub 2018 Feb 14.
- Results publication: PubMed 10352603Blackmore CC, Emerson SS, Mann FA, Koepsell TD. Cervical spine imaging in patients with trauma: determination of fracture risk to optimize use. Radiology. 1999 Jun;211(3):759-65. doi: 10.1148/radiology.211.3.r99jn22759.
- Results publication: PubMed 29379812Aktas N, Gulacti U, Lok U, Aydin I, Borta T, Celik M. Characteristics of the Traumatic Forensic Cases Admitted To Emergency Department and Errors in the Forensic Report Writing. Bull Emerg Trauma. 2018 Jan;6(1):64-70. doi: 10.29252/beat-060110.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doaa Mohamed Abd El Rahman, Assistant Professor study director
Doaa Mohamed Abd El Rahman
Ali Mohamedein Mohamed, professor study director
Ali Mohamedein Mohamed
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa Khalid Mohamed Ismail, demonstrator (+201007097882, marwakhalid@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of medico-legal aspects of traumatic spinal injury cases includind 1 mode of trauma: suicidal, homicidal or accidental 2 causes :road traffic injuries, fall from height, assault from other...etc 3 Pattern: type and level of the injury. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06717503, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.