NCT05678803

Brief Summary

The subaxial cervical spine consists of levels C3 through C7 and includes both the bony anatomy as well as the ligamentous anatomy. Injuries to the subaxial cervical spine can be bony, discoligamentous or a combination of both (1). Cervical spine trauma is common resulting from high energy trauma such as falling from height and motor vehicle accident (2). Devastating sequelae of subaxial cervical spine trauma include quadriplegia, functional loss, and permanent disability

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 9, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

12 months

First QC Date

February 9, 2022

Last Update Submit

May 9, 2023

Conditions

Cervical Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • Short-Term Outcomes Of Subaxial Cervical Injuries in Assiut University Trauma Center

    Neck disability index It is a standard instrument for measuring self-rated disability due to neck pain and is used by both clinicians and researchers. Each of the 10 items scores from 0 to 5. The maximum score is 50. The obtained score can be multiplied by two to produce a percentage score

    1 year

Interventions

xrays and CTOTHER

A dedicated sheet will be used to record patients' data including all demographic data, detailed analysis of the mechanism of injury, time of injury, time and details of surgery (if any), neurological status on admission and all radiological findings. All patients will undergo plain X-rays and CT imaging. Patients with suspected discoligamentous injuries and/or neurological deficits will also be assessed by MRI.

Eligibility Criteria

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

All patients presenting with subaxial cervical spine injuries with and without cervical cord injury between January 2022 and December 2022.

You may qualify if:

  • All patients presenting with subaxial cervical spine injuries with and without cervical cord injury between January 2022 and December 2022.

You may not qualify if:

  • Patients who refuse to participate in the study 2- Patients who are not available for 6 weeks follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peternabil049@Gmail.Com

Asyut, 71111, Egypt

Location

Related Publications (6)

  • Stauffer ES. Subaxial injuries. Clin Orthop Relat Res. 1989 Feb;(239):30-9.

    PMID: 2912631BACKGROUND

  • Feuchtbaum E, Buchowski J, Zebala L. Subaxial cervical spine trauma. Curr Rev Musculoskelet Med. 2016 Dec;9(4):496-504. doi: 10.1007/s12178-016-9377-0.

    PMID: 27864669BACKGROUND

  • Schroeder GD, Vaccaro AR. Cervical Spine Injuries in the Athlete. J Am Acad Orthop Surg. 2016 Sep;24(9):e122-33. doi: 10.5435/JAAOS-D-15-00716.

    PMID: 27479833BACKGROUND

  • Kwon BK, Vaccaro AR, Grauer JN, Fisher CG, Dvorak MF. Subaxial cervical spine trauma. J Am Acad Orthop Surg. 2006 Feb;14(2):78-89. doi: 10.5435/00124635-200602000-00003.

    PMID: 16467183BACKGROUND

  • Pourtaheri S, Emami A, Sinha K, Faloon M, Hwang K, Shafa E, Holmes L Jr. The role of magnetic resonance imaging in acute cervical spine fractures. Spine J. 2014 Nov 1;14(11):2546-53. doi: 10.1016/j.spinee.2013.10.052. Epub 2013 Nov 22.

    PMID: 24269913BACKGROUND

  • Shaheen AA, Omar MT, Vernon H. Cross-cultural adaptation, reliability, and validity of the Arabic version of neck disability index in patients with neck pain. Spine (Phila Pa 1976). 2013 May 1;38(10):E609-15. doi: 10.1097/BRS.0b013e31828b2d09.

    PMID: 23429690BACKGROUND

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 9, 2022

First Posted

January 10, 2023

Study Start

March 10, 2022

Primary Completion

March 9, 2023

Study Completion

March 9, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

EG(1)