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

Odontoid Fractures Type II Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283998
• Other study ID #: 06-Odont-02
• Status: Completed
• Phase: Phase 4
• First received: January 30, 2006
• Last updated: March 25, 2014
• Start date: January 2006
• Est. completion date: March 2012

Study information

• Verified date: March 2014
• Source: AO Clinical Investigation and Documentation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: March 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Odontoid Fractures Type II

Intervention

Procedure:
• surgical versus conservative treatment
Surgical treatment of fractures versus conservative stabilization

Locations

Country	Name	City	State
United States	Emory University SOM: Orthopedics	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
AO Clinical Investigation and Documentation	AOSpine North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life using the Neck disability Index		12 months	No
Primary	Quality of life using the SF-36		12 months	No
Primary	Proportion of bony fusion between the two treatments		6 months	No
Primary	Proportion rate of non-union between the two treatments		6 months	No
Secondary	Rate of complications		12 months	No
Secondary	Cervical range of motion		12 months	No
Secondary	Identify the risk factors for a poor outcome independent of treatment intervention		12 months	No