NCT06717503

Brief Summary

  1. 1.Describe different medico-legal aspects of TSI (mode of trauma, cause and Pattern of spinal injuries).
  2. 2.Assess the outcome of TSI in studied cases.
  3. 3.Associate type of trauma with the different patterns of acute spinal injuries.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

December 6, 2024

Status Verified

November 1, 2024

Enrollment Period

12 months

First QC Date

November 27, 2024

Last Update Submit

December 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

    baseline

Interventions

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)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • All patients presenting with acute TSI regardless level of injury, or neurological status.

You may not qualify if:

  • Patients have congenital anomalies, neurological defects or disability before trauma.
  • Patients with pathological spinal cord diseases were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 22985366BACKGROUND
  • Vazquez 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.

    PMID: 18096510BACKGROUND
  • Singh 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.

    PMID: 25278785BACKGROUND
  • Soreide K. Epidemiology of major trauma. Br J Surg. 2009 Jul;96(7):697-8. doi: 10.1002/bjs.6643. No abstract available.

    PMID: 19526611BACKGROUND
  • Kumar 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.

    PMID: 29454115BACKGROUND
  • Blackmore 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.

    PMID: 10352603BACKGROUND
  • Aktas 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.

    PMID: 29379812BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Doaa Mohamed Abd El Rahman, Assistant Professor

    Doaa Mohamed Abd El Rahman

    STUDY DIRECTOR
  • Ali Mohamedein Mohamed, professor

    Ali Mohamedein Mohamed

    STUDY DIRECTOR

Central Study Contacts

Marwa Khalid Mohamed Ismail, demonstrator

CONTACT

Zaghloul Thabet Mohamed, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator at forensic medicine and clinical toxicology

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 5, 2024

Study Start

January 1, 2025

Primary Completion

December 31, 2025

Study Completion

January 31, 2026

Last Updated

December 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share