NCT02432495

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
Last Updated

May 4, 2015

Status Verified

April 1, 2015

Enrollment Period

5.8 years

First QC Date

April 20, 2015

Last Update Submit

April 28, 2015

Conditions

Spinal Fractures

Outcome Measures

Primary Outcomes (2)

  • 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

  • radiographic outcome (documentation of boney union)

    documentation of boney union compared in both procedure groups

    at least 60 months follow up

Study Arms (2)

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

Other: ANTERIOR SCREW FIXATION

Halo 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

Other: HALOV VEST IMMOBILIZATION

Interventions

ANTERIOR SCREW FIXATIONOTHER

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

Anterior screw fixation
HALOV VEST IMMOBILIZATIONOTHER

Patients aged 65 years or older with an ASA score of 2 or higher who had undergone halo immobilization of type II odontoid fractures

Halo immobilization

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients aged 65 years or older with an ASA score of 2 or higher who had undergone either anterior screw fixation or halo immobilization of type II odontoid fractures

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 20, 2015

First Posted

May 4, 2015

Study Start

April 1, 2008

Primary Completion

January 1, 2014

Last Updated

May 4, 2015

Record last verified: 2015-04