Skip to main content
OpenTrials
Completed

NCT Number: NCT05678803

Short-Term Outcomes Of Subaxial Cervical Injuries

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

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Initially, all patients with subaxial cervical spine fractures require immobilization in a rigid cervical orthosis (2). Patients receiving conservative treatment are often prescribed a rigid cervical or cervicothoracic orthosis for 6 to 12 weeks with regular follow-up and interval radiographs to assess alignment.

Patients with fractures deemed unstable or neurologic compromise should undergo decompression and stabilization. Intervention within 24 hours of injury leads to better improvement in ASIA scores (3). The recent AO Spine Subaxial Classification system relies essentially on MSCT evaluation (Reference). However, MRI is superior to CT scans for evaluating the spinal cord, nerve roots, disc, and ligamentous structures in the cervical spine (4).

Even though the investigators receive and treat a large number of patients with various subaxial cervical injuries in Assiut University Hospital each year, there is no consensus about the best treatment options and uncertainty about the outcome of these treatments.

In this study, the participants will assess the short-term outcomes of all patients with subaxial cervical fractures who will be admitted to the participants' center regardless of the neurological status or treatment type used.

The participants will also create a detailed prospective database to be used for another later study on the long-term outcome

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

xrays and CT

Other

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.

Primary outcomes

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

    Time frame: 1 year

    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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2023
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.