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

Spinal Fractures Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432495
• Other study ID #: 2008/10
• Status: Completed
• Phase: N/A
• First received: April 20, 2015
• Last updated: April 28, 2015
• Start date: April 2008

Study information

• Verified date: April 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Exclusion Criteria:

• type III odontoid fractures

• patients with incomplete data sets

• patients with penetrating mechanism of injury or congenital cervical spine anomalies

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Spinal Fractures

Intervention

Other:
• 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
• HALOV VEST IMMOBILIZATION
Patients aged 65 years or older with an ASA score of 2 or higher who had undergone halo immobilization of type II odontoid fractures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neurological deficits	Neurologic deficits measured including the CSOQ (Cervical Spine Outcome Questionnaire) before and after surgery as well as compared in both procedure groups	at least 60 months follow up	No
Primary	radiographic outcome (documentation of boney union)	documentation of boney union compared in both procedure groups	at least 60 months follow up	No