Phase 4 Study Comparing Surigcal to Conservative Management of Type 2 Odontoid Fractures

AO Clinical Investigation and Publishing Documentation1 site in 1 country166 target enrollmentJanuary 2006

ConditionsOdontoid Fractures Type II

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Odontoid Fractures Type II
Sponsor: AO Clinical Investigation and Publishing Documentation
Enrollment: 166
Locations: 1
Primary Endpoint: Quality of life using the Neck disability Index
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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 >/= 65 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.

Registry

clinicaltrials.gov

Start Date

January 2006

End Date

March 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AO Clinical Investigation and Publishing Documentation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All new type II odontoid fractures including \< those in which the fracture line crosses into the body of C2 \< as long as it doesn't enter the superior articular process of C2
•Stable and unstable fractures
•\< 3 months postinjury
•No previous treatment for an odontoid fracture

Exclusion Criteria

•Pathologic fractures unrelated to osteoporosis
•Severe dementia or other severe mental health problem if there is no consentable surrogate available
•Participating in other trials or unlikely to attend follow-ups

Outcomes

Primary Outcomes

Quality of life using the Neck disability Index

Time Frame: 12 months

Quality of life using the SF-36

Time Frame: 12 months

Proportion of bony fusion between the two treatments

Time Frame: 6 months

Proportion rate of non-union between the two treatments

Time Frame: 6 months

Secondary Outcomes

Rate of complications(12 months)
Cervical range of motion(12 months)
Identify the risk factors for a poor outcome independent of treatment intervention(12 months)