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Cervical Injury SpineNCT06297395

Subaxial Cervical Traumatic Injuries

An observational study of Cervical Injury Spine, run by Assiut University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 assess the mid-term outcomes of treating subaxial cervical traumatic injury 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 Injury Spine
How many people
100 participants
Where
No sites listed yet
Study dates
1 Mar 2024to 1 Mar 2025
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
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Peter Philip Phily Ishaq, Resident contact

01276176649

Peter.15235761@med.aun.edu.eg

About this study

Official title: Mid-Term Outcomes Of Subaxial Cervical Traumatic Injuries in Assiut University Trauma Center

The aim of this study is to assess the mid-term outcomes of treating subaxial cervical traumatic injury cases admitted to the Trauma Unit of Assiut University Hospital.

Read the 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.

What is being measured

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

  1. Percentage of improvement

    Percentage of improvement in NDI (Arabic version) following conservative and surgical treatment during the follow up visits

    Measured: Baseline

Secondary outcomes (8)

  1. Patient Outcomes

    AO Spine PROST

    Measured: Baseline

  2. Complication

    Mortality rate

    Measured: Baseline

  3. rehabilitation

    Improvement of neurological deficit by ASIA score

    Measured: Baseline

  4. Complication

    Incidence and rate of complications

    Measured: Baseline

  5. rehabilitation

    Return to work and activity of daily living.

    Measured: Baseline

  6. Complication

    Need for admission to the Intensive Care unit.

    Measured: Baseline

  7. Complication

    Post traumatic respiratory distress.

    Measured: Baseline

  8. Complication

    Fracture healing - pseudarthrosis - implant failure.

    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 posted7 Mar 2024
  2. Study start1 Mar 2024 (estimated)
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Mar 2025 (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
Case only
Time perspective
Other
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06297395
Sponsor's protocol ID
Cervical Traumatic Inj
Status last verified
Feb 2024
First submitted
1 Feb 2024
Last updated
7 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

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

    PubMed 2912631

  • 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.

    PubMed 27864669

  • Aebi M. Surgical treatment of upper, middle and lower cervical injuries and non-unions by anterior procedures. Eur Spine J. 2010 Mar;19 Suppl 1(Suppl 1):S33-9. doi: 10.1007/s00586-009-1120-8. Epub 2009 Oct 14.

    PubMed 19826842

  • 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.

    PubMed 24269913

  • Vaccaro AR, Koerner JD, Radcliff KE, Oner FC, Reinhold M, Schnake KJ, Kandziora F, Fehlings MG, Dvorak MF, Aarabi B, Rajasekaran S, Schroeder GD, Kepler CK, Vialle LR. AOSpine subaxial cervical spine injury classification system. Eur Spine J. 2016 Jul;25(7):2173-84. doi: 10.1007/s00586-015-3831-3. Epub 2015 Feb 26.

    PubMed 25716661

  • 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.

    PubMed 23429690

  • Sadiqi S, Oner FC. A disease-specific patient reported outcome instrument for spine trauma is developed, validated and available! Re: Andrzejowski et al. Measuring functional outcomes in major trauma: can we do better? Eur J Trauma Emerg Surg. 2023 Jun;49(3):1605-1606. doi: 10.1007/s00068-022-02167-8. Epub 2022 Nov 15. No abstract available.

    PubMed 36378305

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Injury Spine, run by Assiut University.

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 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Peter Philip Phily Ishaq, Resident (01276176649, Peter.15235761@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of improvement (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 NCT06297395, which also lists 7 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 7 Mar 2024.

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