- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03149497
Anterior Only Surgery for Management of Traumatic Subaxial Cervical Spine Instability
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Assiut, Egypt, 088
- Assiut University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Acute traumatic cases of adult patients with sub axial cervical spine injury presenting to trauma unit of Assiut university hospital
Exclusion Criteria:
- Patients who need cervical corpectomy.
- Pediatric injuries
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: improved anterior approach only in traumatic cervical spine
|
evaluation of efficacy of single approach
|
Active Comparator: failed anterior approach only in traumatic cervical spine
|
evaluation of efficacy of single approach
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiological analysis
Time Frame: 6 months
|
Fusion state by: Presence of crossing bone, mobility on motion films and CT scan |
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- assiutU100
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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