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

AO Clinical Investigation and Publishing Documentation

Status and phase

Completed

Phase 4

Conditions

Odontoid Fractures Type II

Treatments

Procedure: surgical versus conservative treatment

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00283998

06-Odont-02

Details and patient eligibility

About

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.

Enrollment

166 estimated patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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
Age 65+
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