Recent and Non United Odontoid Fractures

Not Applicable

Completed

• Conditions: Odontoid Process
• Interventions: Other: non operative treatment for odontoid non unions; Procedure: surgical treatment

• Registration Number: NCT02359656
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2013-01
• Study Completion: 2015-01
• Study First Submitted: 2015-01-31
• Status Verified: 2015-02
• Study First Submitted QC: 2015-02-04
• Last Update Submitted: 2015-02-04
• Study First Posted: 2015-02-10
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non operative treatment	non operative treatment for odontoid non unions	specif non operative treatment protocol
operative treatment	surgical treatment	dorsal atlanto-axial C1-C2 Arthrodesis

Primary Outcome Measures

Name	Time	Method
Functional outcome (range of motion) and radiographic (bony fusion) long - term results in geriatric patients who had undergone surgical or non - operative treatment of odontoid non - unions.	follow up of at least 5 years

Secondary Outcome Measures

Name	Time	Method
Composite outcome measure consisting of multiple measures as late bony fusion, cervical spin, neurological sequalea	follow up of at least 5 years