Back to resultsComparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly
Primary Purpose
Odontoid Fractures Type II
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
surgical versus conservative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Odontoid Fractures Type II focused on measuring Odontoid, Type II fractures, Elderly patients, Surgical vs. conservative treatment
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 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
Sites / Locations
- Emory University SOM: Orthopedics
Outcomes
Primary Outcome Measures
Quality of life using the Neck disability Index
Quality of life using the SF-36
Proportion of bony fusion between the two treatments
Proportion rate of non-union between the two treatments
Secondary Outcome Measures
Rate of complications
Cervical range of motion
Identify the risk factors for a poor outcome independent of treatment intervention
Full Information
NCT ID
NCT00283998
First Posted
January 30, 2006
Last Updated
March 25, 2014
Sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
AOSpine North America
1. Study Identification
Unique Protocol Identification Number
NCT00283998
Brief Title
Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly
Official Title
Phase 4 Study Comparing Surigcal to Conservative Management of Type 2 Odontoid Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
AOSpine North America
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Odontoid Fractures Type II
Keywords
Odontoid, Type II fractures, Elderly patients, Surgical vs. conservative treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
166 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
surgical versus conservative treatment
Intervention Description
Surgical treatment of fractures versus conservative stabilization
Primary Outcome Measure Information:
Title
Quality of life using the Neck disability Index
Time Frame
12 months
Title
Quality of life using the SF-36
Time Frame
12 months
Title
Proportion of bony fusion between the two treatments
Time Frame
6 months
Title
Proportion rate of non-union between the two treatments
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rate of complications
Time Frame
12 months
Title
Cervical range of motion
Time Frame
12 months
Title
Identify the risk factors for a poor outcome independent of treatment intervention
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander R Vaccaro, MD
Organizational Affiliation
Th. Jefferson University Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University SOM: Orthopedics
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
35037
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly
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