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OpenTrials
Completed

NCT Number: NCT02432495

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ANTERIOR SCREW FIXATION

Other

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

Other

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

Primary outcomes

  1. neurological deficits

    Time frame: 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

  2. radiographic outcome (documentation of boney union)

    Time frame: at least 60 months follow up

    documentation of boney union compared in both procedure groups

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2008
Primary completion
2014
First posted
May 4, 2015
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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