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Recent and Non United Odontoid Fractures

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Medical University of Vienna

Status

Completed

Conditions

Odontoid Process

Treatments

Other: non operative treatment for odontoid non unions
Procedure: surgical treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02359656
1127/2009

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 2 patient groups

non operative treatment
Other group
Description:
specif non operative treatment protocol
Treatment:
Other: non operative treatment for odontoid non unions
operative treatment
Other group
Description:
dorsal atlanto-axial C1-C2 Arthrodesis
Treatment:
Procedure: surgical treatment

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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