Anterior Screw Fixation Versus Halo Immobilization of Type II Odontoid Fractures in Geriatric Patients With Increased Anesthesia Risk

Completed

• Conditions: Spinal Fractures
• Interventions: Other: ANTERIOR SCREW FIXATION; Other: HALOV VEST IMMOBILIZATION

• Registration Number: NCT02432495
• Lead Sponsor: Medical University of Vienna

Brief Summary

The management of type II odontoid fractures in geriatric trauma victims remains a source of substantial controversy. The purpose of this study was to compare anterior screw fixation with halo-vest-immobilization in patients with type II odontoid fractures.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2014-01
• Status Verified: 2015-04
• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-28
• Last Update Submitted: 2015-04-28
• Study First Posted: 2015-05-04
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• patients aged 65 years or older with an ASA (= American society of anesthesiologists) score of 2 or higher
• complete sets of collected data and a follow-up monitoring of at least five years

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Exclusion Criteria

• type III odontoid fractures
• patients with incomplete data sets
• patients with penetrating mechanism of injury or congenital cervical spine anomalies

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anterior screw fixation	ANTERIOR SCREW FIXATION	Patients aged 65 years or older with an ASA score of 2 or higher who had undergone anterior screw fixation of type II odontoid fractures
Halo immobilization	HALOV VEST IMMOBILIZATION	Patients aged 65 years or older with an ASA score of 2 or higher who had undergone of halo immobilization of type II odontoid fractures

Primary Outcome Measures

Name	Time	Method
radiographic outcome (documentation of boney union)	at least 60 months follow up	documentation of boney union compared in both procedure groups
neurological deficits	at least 60 months follow up	Neurologic deficits measured including the CSOQ (Cervical Spine Outcome Questionnaire) before and after surgery as well as compared in both procedure groups