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OpenTrials
Completed

NCT Number: NCT02359656

Recent and Non United Odontoid Fractures

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.

Completed

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

surgical treatment

Procedure

C1-C1 arthrodesis

non operative treatment for odontoid non unions

Other

specific non operative treatment protocol

Primary outcomes

  1. 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.

    Time frame: follow up of at least 5 years

Secondary outcomes

  1. Composite outcome measure consisting of multiple measures as late bony fusion, cervical spin, neurological sequalea

    Time frame: follow up of at least 5 years

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Recent and Non United Odontoid Fractures: Clinical and Biomechanical Aspects

Important dates

Study start
2006
Primary completion
2013
Study completion
2015
First posted
Feb 10, 2015
Registry last updated
Feb 10, 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.