Spinal FracturesNCT02432495
Anterior Screw Fixation Versus Halo Immobilization of Type II Odontoid Fractures in Geriatric Patients With Increased Anesthesia Risk
An observational study of Spinal Fractures, run by Medical University of Vienna.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Fractures
- What is being tested?
- ANTERIOR SCREW FIXATION and HALOV VEST IMMOBILIZATION
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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
Who may be able to join
- 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
Who cannot join
- type III odontoid fractures
- patients with incomplete data sets
- patients with penetrating mechanism of injury or congenital cervical spine anomalies
About this study
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.
- Conditions
- Spinal Fractures
- Being tested
- ANTERIOR SCREW FIXATION, HALOV VEST IMMOBILIZATION
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: HALOV VEST IMMOBILIZATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurological deficits
Neurologic deficits measured including the CSOQ (Cervical Spine Outcome Questionnaire) before and after surgery as well as compared in both procedure groups
Measured: at least 60 months follow up
radiographic outcome (documentation of boney union)
documentation of boney union compared in both procedure groups
Measured: at least 60 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startApr 2008
- Primary completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FracturesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Joestl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432495
- Sponsor's protocol ID
- 2008/10
- Status last verified
- Apr 2015
- First submitted
- 20 Apr 2015
- Last updated
- 4 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Screw Fixation Versus Halo Immobilization of Type II Odontoid Fractures in Geriatric Patients With Increased Anesthesia Risk
- ClinicalTrials.gov ID
- NCT02432495
- Acronym / sponsor ID
- 2008/10
- Conditions
- Spinal Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jan 2014 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior screw fixation | – | Other: ANTERIOR SCREW FIXATIONPatients 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 | – | Other: HALOV VEST IMMOBILIZATIONPatients aged 65 years or older with an ASA score of 2 or higher who had undergone of halo immobilization of type II odontoid fractures |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- type III odontoid fractures
- patients with incomplete data sets
- patients with penetrating mechanism of injury or congenital cervical spine anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANTERIOR SCREW FIXATIONPatients 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 |
| HALOV VEST IMMOBILIZATIONPatients aged 65 years or older with an ASA score of 2 or higher who had undergone halo immobilization of type II odontoid fractures | Other | Halo immobilization |
Primary outcome
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
radiographic outcome (documentation of boney union)
Time frame: at least 60 months follow up
documentation of boney union compared in both procedure groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Fractures, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neurological deficits (time frame: at least 60 months follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.