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Cervical Spine FractureNCT05842694

Mid-Term Outcomes Of Fracture Odontoid Management in Assiut University

An observational study of Cervical Spine Fracture, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cervical Spine Fracture
How many people
15 participants
Where
1 siteEgypt
Study dates
10 May 2023to Jun 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut University Hospital

    Asyut

Other trials in Egypt

About this study

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.

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. follow up of patients with odontoid fracture using neck disability index

    Percentage of improvement in neck disability index following conservative and surgical treatment during the follow up visits

    Measured: baseline

Secondary outcomes (1)

  1. rate of complication

    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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start10 May 2023 (estimated)
  3. Primary completionMay 2024 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05842694
Sponsor's protocol ID
follow up of Odontoid fracture
Status last verified
May 2023
First submitted
31 Mar 2023
Last updated
6 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Julien TD, Frankel B, Traynelis VC, Ryken TC. Evidence-based analysis of odontoid fracture management. Neurosurg Focus. 2000 Jun 15;8(6):e1. doi: 10.3171/foc.2000.8.6.2.

    PubMed 16859271

  • Chi YL, Wang XY, Xu HZ, Lin Y, Huang QS, Mao FM, Ni WF, Wang S, Dai LY. Management of odontoid fractures with percutaneous anterior odontoid screw fixation. Eur Spine J. 2007 Aug;16(8):1157-64. doi: 10.1007/s00586-007-0331-0. Epub 2007 Mar 3.

    PubMed 17334793

  • Grauer JN, Shafi B, Hilibrand AS, Harrop JS, Kwon BK, Beiner JM, Albert TJ, Fehlings MG, Vaccaro AR. Proposal of a modified, treatment-oriented classification of odontoid fractures. Spine J. 2005 Mar-Apr;5(2):123-9. doi: 10.1016/j.spinee.2004.09.014.

    PubMed 15749611

  • Cutler HS, Guzman JZ, Lee NJ, Kothari P, Kim JS, Shin JI, Leven DM, Cho SK. Short-Term Complications of Anterior Fixation of Odontoid Fractures. Global Spine J. 2018 Feb;8(1):47-56. doi: 10.1177/2192568217698132. Epub 2017 May 16.

    PubMed 29456915

  • White AP, Hashimoto R, Norvell DC, Vaccaro AR. Morbidity and mortality related to odontoid fracture surgery in the elderly population. Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S146-57. doi: 10.1097/BRS.0b013e3181d830a4.

    PubMed 20407346

  • Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.

    PubMed 1834753

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Spine Fracture, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

follow up of patients with odontoid fracture using neck disability index (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05842694, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

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