Clinical Trial on Cervical Injury Spine - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Cervical Injury Spine

Detailed Description

Injuries to the subaxial cervical spine can be bony, discoligamentous or a combination of both. Cervical spine trauma is common resulting from high energy trauma such as falling from height and motor vehicle accident . The subaxial cervical spine is a common site of cervical injury with more than 50 % of injuries being located between C5 and C7 MRI is superior to CT scans for evaluating the spinal cord, nerve roots, disc, and ligamentous structures in the cervical spine There are a couple of classification systems that have been devised The first is the Subaxial Injury Classification System (SLIC). This classification stratifies the type of fracture, the competency of the DLC, and the patient's neurologic status with numerical values to determine the course of treatment.

A second classification system is the AO Spine Subaxial Cervical Spine Injury Classification. The AO Spine SCICS classifies injuries based on 4 parameters: injury morphology, facet involvement, neurological status, and case-specific modifiers 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 .

Although we receive and treat a large number of patients with various subaxial cervical traumatic injuries in Assiut University Hospital each year, there is uncertainty about the midterm outcome of the treatment we provide.

In this study, The investigators will assess the mid-term outcomes of all patients with subaxial cervical traumatic injuries who complete a minimum one year follow up regardless of the neurological status or treatment type used.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Peter Philip Phily Ishaq, Resident
Phone Number: 01276176649
Email: Peter.15235761@med.aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients fulfilling the inclusion criteria presenting to our hospital will be included in the study (Total coverage). Based on hospital records, we usually receive around 100 cases each year. We will also include all patients prospectively recorded in our data base starting from 11-01-2022. This data base includes 96 to date.

Description

Inclusion Criteria:

All patients presenting with subaxial cervical spine traumatic injuries with and without cervical cord injury who complete a minimum of one year follow up

Exclusion Criteria:

Patients who refuse to participate in the study Patients with pathological fractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of improvement Time Frame: Baseline	Percentage of improvement in NDI (Arabic version) following conservative and surgical treatment during the follow up visits	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication Time Frame: Baseline	Incidence and rate of complications	Baseline
Patient Outcomes Time Frame: Baseline	AO Spine PROST	Baseline
Complication Time Frame: Baseline	Mortality rate	Baseline
rehabilitation Time Frame: Baseline	Improvement of neurological deficit by ASIA score	Baseline
rehabilitation Time Frame: Baseline	Return to work and activity of daily living.	Baseline
Complication Time Frame: Baseline	Need for admission to the Intensive Care unit.	Baseline
Complication Time Frame: Baseline	Post traumatic respiratory distress.	Baseline
Complication Time Frame: Baseline	Fracture healing - pseudarthrosis - implant failure.	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

Study Director: Mohammad El- Sharkawi, Prof, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)