Anterior Only Surgery for Management of Traumatic Subaxial Cervical Spine Instability

NCT ID: NCT03149497

Last Updated: 2017-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Cervical Spine Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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improved anterior approach only in traumatic cervical spine

Group Type ACTIVE_COMPARATOR

anterior approach only in cervical spine trauma

Intervention Type PROCEDURE

evaluation of efficacy of single approach

failed anterior approach only in traumatic cervical spine

Group Type ACTIVE_COMPARATOR

anterior approach only in cervical spine trauma

Intervention Type PROCEDURE

evaluation of efficacy of single approach

Interventions

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anterior approach only in cervical spine trauma

evaluation of efficacy of single approach

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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arsany botros saleh

OTHER

Sponsor Role lead

Responsible Party

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arsany botros saleh

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Assiut University

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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assiutU100

Identifier Type: -

Identifier Source: org_study_id

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