Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05945550
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-07-06
Brief Title:
Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery Is There a Difference
Sponsor:
Methodist Health System
Organization:
Methodist Health System
Study Overview
Official Title:
Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery Is There a Difference
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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:
To identify the current mortality rate for initial ALIF procedures Establishprove mortality rates for this operation have dropped in the past decade
Detailed Description:
Establish the mortality rate for re-do ALIF procedures ie is it different than that of initial ALIF procedures and - if so - postulate that there are interventions that can be done in the pre-operative period to ameliorate that risk This study is not designed to prove the latter hypothesis
This is a single sample study where medical records will be searched by CPT codes for ALIF codes eg 22558 22585 22845 etc by trained researchers at participating Methodist facilities going back 5-10 years to see if 1500-3500 cases can be identified within that time period
This is a single sample study where medical records will be searched by CPT codes for ALIF codes eg 22558 22585 22845 etc by trained researchers at participating Methodist facilities going back 5-10 years to see if 1500-3500 cases can be identified within that time period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None