Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266929
Status:
COMPLETED
Last Update Posted:
2017-08-11
First Post:
2005-12-19
Brief Title:
Treatment of Type II Odontoid Fractures Among the Elderly
Sponsor:
AOSpine North America Research Network
Organization:
AOSpine North America Research Network
Study Overview
Official Title:
Comparing Surgical to Conservative Management in the Treatment of Type II Odontoid Fractures Among the Elderly
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None