Clinical Trials Directory

Trials / Completed

CompletedNCT00266929

Treatment of Type II Odontoid Fractures Among the Elderly

Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly

Status
Completed
Phase
Study type
Observational
Enrollment
159 (actual)
Sponsor
AOSpine North America Research Network · Network
Sex
All
Age
64 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to compare the safety and effectiveness of surgical versus conservative management of type II odontoid fractures among patients \> 64 years of age. Of secondary interest is to determine if there are differences in outcomes between anterior screw fixation and posterior fusion of these fractures.

Detailed description

Hypotheses are as follows: * Patients receiving surgical management will exhibit better disease specific health and general health related quality of life measures compared to those managed conservatively. * The rate of radiographic bony fusion will be greater among elderly patients receiving surgical fixation compared to patients receiving conservative management. * The rate of non union will be greater in the conservative group compared to the surgical group. * The complication rate will be higher in the surgical group due to the nature of the intervention though the rate of severe and serious complications will be low.

Conditions

Interventions

TypeNameDescription
PROCEDUREsurgicalsurgical treatment of odontoid fractures
PROCEDUREconservative treatmentconservative stabilization of fractures

Timeline

Start date
2005-12-01
Primary completion
2010-05-01
Completion
2010-05-01
First posted
2005-12-20
Last updated
2017-08-11

Locations

15 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT00266929. Inclusion in this directory is not an endorsement.