Traumatic Cervical Spine InstabilityNCT03149497
Anterior Only Surgery for Management of Traumatic Subaxial Cervical Spine Instability
A study testing anterior approach only in cervical spine trauma in people with Traumatic Cervical Spine Instability, run by arsany botros saleh at 1 site in Egypt.
Trial summary
Classic management of cervical spine sublaxation and dislocation is combined anterior and posterior approach. Unfortunately there are disadvantages for this approach like: increasing morbidity related to each approach, increasing surgical costs, increasing operative time as well as the risk of blood loss. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Traumatic Cervical Spine Instability
- What is being tested?
- anterior approach only in cervical spine trauma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 1 Sep 2018
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute traumatic cases of adult patients with sub axial cervical spine injury presenting to trauma unit of Assiut university hospital
Who cannot join
- Patients who need cervical corpectomy.
- Pediatric injuries
Trial locations and contacts
1 site in 1 country.
About this study
Classic management of cervical spine sublaxation and dislocation is combined anterior and posterior approach. Unfortunately there are disadvantages for this approach like: increasing morbidity related to each approach, increasing surgical costs, increasing operative time as well as the risk of blood loss.
Anterior approach has the advantages of supine position, less surgical trauma and direct anterior decompression of neural elements. Disadvantages include less mechanical stability and postoperative dysphagia.
- Conditions
- Traumatic Cervical Spine Instability
- Being tested
- anterior approach only in cervical spine trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior approach only in cervical spine traumaProcedure or surgery
evaluation of efficacy of single approach
| Study group | Role | What they receive |
|---|---|---|
| improved anterior approach only in traumatic cervical spine | Active comparator | Not described Receives: Procedure: anterior approach only in cervical spine trauma |
| failed anterior approach only in traumatic cervical spine | Active comparator | Not described Receives: Procedure: anterior approach only in cervical spine trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological analysis
Fusion state by:
Presence of crossing bone, mobility on motion films and CT scan
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Mar 2017
- Primary completion1 Mar 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Cervical Spine InstabilityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- arsany botros saleh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, arsany botros saleh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149497
- Sponsor's protocol ID
- assiutU100
- Status last verified
- May 2017
- First submitted
- 8 May 2017
- Last updated
- 11 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Only Surgery for Management of Traumatic Subaxial Cervical Spine Instability
- ClinicalTrials.gov ID
- NCT03149497
- Acronym / sponsor ID
- assiutU100
- Conditions
- Traumatic Cervical Spine Instability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- arsany botros salehUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 11 May 2017 (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.
Classic management of cervical spine sublaxation and dislocation is combined anterior and posterior approach. Unfortunately there are disadvantages for this approach like: increasing morbidity related to each approach, increasing surgical costs, increasing operative time as well as the risk of blood loss.
Anterior approach has the advantages of supine position, less surgical trauma and direct anterior decompression of neural elements. Disadvantages include less mechanical stability and postoperative dysphagia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| improved anterior approach only in traumatic cervical spine | Active comparator | Procedure: anterior approach only in cervical spine trauma |
| failed anterior approach only in traumatic cervical spine | Active comparator | Procedure: anterior approach only in cervical spine trauma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute traumatic cases of adult patients with sub axial cervical spine injury presenting to trauma unit of Assiut university hospital
Key exclusion criteria (2 listed)
- Patients who need cervical corpectomy.
- Pediatric injuries
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 |
|---|---|---|
| anterior approach only in cervical spine traumaevaluation of efficacy of single approach | Procedure or surgery | failed anterior approach only in traumatic cervical spine, improved anterior approach only in traumatic cervical spine |
Primary outcome
Radiological analysis
Time frame: 6 months
Fusion state by: Presence of crossing bone, mobility on motion films and CT scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
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?
A study testing anterior approach only in cervical spine trauma in people with Traumatic Cervical Spine Instability, run by arsany botros saleh 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 2 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 11 May 2017. 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?
Radiological analysis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2017.