Cervical Spinal Cord InjuryNCT05678803
Short-Term Outcomes Of Subaxial Cervical Injuries
An observational study of Cervical Spinal Cord Injury, run by Assiut University at 1 site in Egypt.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cervical Spinal Cord Injury
- What is being tested?
- xrays and CT
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2022to 9 Mar 2023
- 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 presenting with subaxial cervical spine injuries with and without cervical cord injury between January 2022 and December 2022.
Who may be able to join
- All patients presenting with subaxial cervical spine injuries with and without cervical cord injury between January 2022 and December 2022.
Who cannot join
- 1- Patients who refuse to participate in the study 2- Patients who are not available for 6 weeks follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-Term Outcomes Of Subaxial Cervical Injuries in Assiut University Trauma Center
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
Read the detailed description
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
- Conditions
- Cervical Spinal Cord Injury
- Being tested
- xrays and CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xrays and CTOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-Term Outcomes Of Subaxial Cervical Injuries in Assiut University Trauma Center
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start10 Mar 2022
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cervical Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Nabil Gayed Abdelmalak, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678803
- Sponsor's protocol ID
- Subaxial Cervical Injuries
- Status last verified
- May 2023
- First submitted
- 9 Feb 2022
- Last updated
- 10 May 2023
- 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 2912631Feuchtbaum 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 27864669Schroeder GD, Vaccaro AR. Cervical Spine Injuries in the Athlete. J Am Acad Orthop Surg. 2016 Sep;24(9):e122-33. doi: 10.5435/JAAOS-D-15-00716.
PubMed 27479833Kwon BK, Vaccaro AR, Grauer JN, Fisher CG, Dvorak MF. Subaxial cervical spine trauma. J Am Acad Orthop Surg. 2006 Feb;14(2):78-89. doi: 10.5435/00124635-200602000-00003.
PubMed 16467183Pourtaheri 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 24269913Shaheen 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
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Outcomes Of Subaxial Cervical Injuries in Assiut University Trauma Center
- ClinicalTrials.gov ID
- NCT05678803
- Acronym / sponsor ID
- Subaxial Cervical Injuries
- Conditions
- Cervical Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients presenting with subaxial cervical spine injuries with and without cervical cord injury between January 2022 and December 2022.
Key inclusion criteria (1 listed)
- All patients presenting with subaxial cervical spine injuries with and without cervical cord injury between January 2022 and December 2022.
Key exclusion criteria (1 listed)
- 1- Patients who refuse to participate in the study 2- Patients who are not available for 6 weeks follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| xrays and CTA 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. | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 2912631Stauffer ES. Subaxial injuries. Clin Orthop Relat Res. 1989 Feb;(239):30-9.
- Background: PubMed 27864669Feuchtbaum 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.
- Background: PubMed 27479833Schroeder GD, Vaccaro AR. Cervical Spine Injuries in the Athlete. J Am Acad Orthop Surg. 2016 Sep;24(9):e122-33. doi: 10.5435/JAAOS-D-15-00716.
- Background: PubMed 16467183Kwon BK, Vaccaro AR, Grauer JN, Fisher CG, Dvorak MF. Subaxial cervical spine trauma. J Am Acad Orthop Surg. 2006 Feb;14(2):78-89. doi: 10.5435/00124635-200602000-00003.
- Background: PubMed 24269913Pourtaheri 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.
- Background: PubMed 23429690Shaheen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spinal Cord Injury, 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: finished, as of the sponsor's last update on 10 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Short-Term Outcomes Of Subaxial Cervical Injuries in Assiut University Trauma Center (time frame: 1 year). 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 NCT05678803, 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 10 May 2023.