Treatment of Type II Odontoid Fractures Among the Elderly - Tabular View

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Treatment of Type II Odontoid Fractures Among the Elderly

This study is currently recruiting participants.

Study NCT00266929. Last updated on May 6, 2008. Information provided by AO Clinical Investigation and Documentation

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Treatment of Type II Odontoid Fractures Among the Elderly

Official Title ^†

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

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 > 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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Compare disease-specific health-related quality of life between the surgically and conservatively managed patients using the neck disability index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Compare the proportion of patients with radiographic bony fusion between the surgically and conservatively managed patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Compare the rate of non-union between the surgically and conservatively managed patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Compare the rate of complications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Compare the cervical range of motion between patients receiving anterior screw fixation, posterior fusion, and conservative management [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Identify risk factors for a poor outcome, independent of treatment intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Condition ^†

Neck Injuries
Spinal Injuries

Intervention ^†

Procedure: surgical
Procedure: conservative treatment

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

166

Start Date ^†

December 2005

Completion Date

August 2009

Eligibility Criteria ^†

Inclusion Criteria:

All new type II odontoid fractures including those in which the fracture line crosses into the body of C2
Age > 64
Stable and unstable fractures
< 3 months post-injury
No previous treatment for an odontoid fracture

Exclusion Criteria:

Pathological fractures unrelated to osteoporosis
Severe dementia or severe mental health problems
Participation in other trials or unlikely to attend follow-ups

Gender

Both

Ages

64 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Branko Kopjar, MD

206-221-3349

brankok@u.washington.edu

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00266929

Organization ID

07-GOF-05

Secondary IDs ^††

Study Sponsor ^†

AO Clinical Investigation and Documentation

Collaborators ^††

AOSpine North America

Investigators ^†

Principal Investigator:

Alexander R Vaccaro, MD

Thomas Jefferson University and The Rothman Institute

Information Provided By

AO Clinical Investigation and Documentation

Verification Date

May 2008

First Received Date ^†

December 19, 2005

Last Updated Date

May 6, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.