Mid-Term Outcomes Of Fracture Odontoid Management in Assiut University

May 2, 2023 updated by: Mohamed Osama Mohamed Emam, Assiut University
The aim of this study is to evaluate and assess the mid-term outcomes of treating odontoid fracture cases admitted to the Trauma Unit of Assiut University Hospital.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Odontoid fractures are common fractures of the cervical spine, accounting for 10-15% of all cervical spine fractures. It has a bimodal age distribution as it occurs in both elderly and young patients. The injury generally occurs as a result of strong flexion and extension movement in addition to axial overload. Flexion generally results in anterior subluxation, while extension results in posterior subluxation.

It was classified by Anderson and D'Alonzo Classification in 1974 into three types according to the fracture location. A newer classification was introduced which offered a clearer distinction between type-II and type-III fractures. In this new classification, Type II fractures were further divided into 3 subtypes. The 3 subtypes are labelled A, B, and C. Type II fractures are usually treated surgically through either anterior or posterior approach depending on the fracture pattern as they are characterized by a higher rate of non-union compared to type I and III being in a watershed level between the vertebral and the internal carotid arteries. Nevertheless, the literature is still confusing about the results of anterior surgery in odontoid fractures.

In a recent study by Cutler et al., anterior fixation of odontoid fracture was associated with high morbidity and mortality. In another study, the most commonly reported major complications after odontoid fracture surgery in the elderly include cardiac failure, deep venous thrombosis , stroke, pneumonia, respiratory failure, liver failure, and severe infection.

Despite the fact that we receive and treat a large number of patients with various types of odontoid fractures in Assiut University Hospital, there is no consensus about the best treatment options and uncertainty about the mid and long term outcome of these treatments.

In this study, the investigators will assess the mid-term outcomes (minimum of one year) to all patients with odontoid fracture who are admitted to the Trauma Unit in Assiut University Hospital regardless the treatment type.

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

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

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University Hospital

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

No

Sampling Method

Non-Probability Sample

Study Population

All patients with odontoid fractures presenting to Assiut University Hospital - Department of Orthopaedic and Trauma Surgery who have completed a minimum of 1 year follow up regardless of age, mechanism of injury, neurological status or type of treatment applied

Description

Inclusion Criteria:

  • All patients with odontoid fractures presenting to Assiut University Hospital - Department of Orthopaedic and Trauma Surgery who have completed a minimum of 1 year follow up regardless of age, mechanism of injury, neurological status or type of treatment applied

Exclusion Criteria:

  • Patients who are not available for one year follow-up Patients who refuse to participate in the study

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
follow up of patients with odontoid fracture using neck disability index
Time Frame: baseline
Percentage of improvement in neck disability index following conservative and surgical treatment during the follow up visits
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of complication
Time Frame: baseline
  1. Fracture healing
  2. Incidence and rate of complications (e.g. non-union, post-operative infections, C1-2 Instability, etc…..) Return to work/activity of daily living
baseline

Collaborators and Investigators

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

Sponsor

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 (Anticipated)

May 10, 2023

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Estimate)

May 4, 2023

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • follow up of Odontoid fracture

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Spine Fracture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe