Recent and Non United Odontoid Fractures

NCT ID: NCT02359656

Last Updated: 2015-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2015-01-31

Brief Summary

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The purpose of this study was to determine the clinical and radiographic long - term results in geriatric patients who had undergone surgical or non - operative treatment of odontoid non - unions, with particular regards to late bony fusion, cervical spine motion, neurological sequela, and patient's quality of life.

Detailed Description

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Conditions

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Odontoid Process

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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non operative treatment

specif non operative treatment protocol

Group Type OTHER

non operative treatment for odontoid non unions

Intervention Type OTHER

specific non operative treatment protocol

operative treatment

dorsal atlanto-axial C1-C2 Arthrodesis

Group Type OTHER

surgical treatment

Intervention Type PROCEDURE

C1-C1 arthrodesis

Interventions

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surgical treatment

C1-C1 arthrodesis

Intervention Type PROCEDURE

non operative treatment for odontoid non unions

specific non operative treatment protocol

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

Patients aged 65 years or older who had undergone surgical or non - operative management of odontoid non-unions were sorted and their dataset of follow - up monitoring was examined for completeness and accuracy. According to our inclusion criteria, patients with complete sets of collected data and a follow-up examination of at least five years after treatment of the non - union were finally enrolled in this study. Collected data included variables, such as age, gender, mechanism of injury, fracture type, associated injuries, presence and severity of primary neurological deficits, primary treatment, clinical and neurological outcome after primary treatment, methods of treatment, clinical and radiographic outcome after treatment of the non-union, as well as morbidity and mortality of the patients.

Exclusion Criteria:

Exclusion criteria for this study contain patients with previous or subsequent surgery at the cervical spine level, patients with incomplete data sets, as well as patients with penetrating mechanism of injury or congenital cervical spine anomalies. Incomplete data set was determined, if pertinent clinical or radiographic data of follow - up monitoring (e.g. documents of clinical findings or functional results, radiographs, CT-scanning, e.g.) were missing.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Julian Joestl

Assoc. Prof. Priv. Doz. Dr. Patrick Platzer, PhD, MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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1127/2009

Identifier Type: -

Identifier Source: org_study_id

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