Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-25 @ 2:32 PM
Study NCT ID:
NCT05945550
Status:
UNKNOWN
Last Update Posted:
2023-11-15
First Post:
2023-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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:
Study Overview
Official Title:
Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a Difference?
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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. Establish/prove mortality rates for this operation have dropped in the past decade.
Detailed Description:
Establish the mortality rate for "re-do" ALIF procedures \[i.e., is it different than that of initial ALIF procedures and - if so - postulate that there are interventions that can be done in the pre-operative period to ameliorate that risk. This study is not designed to "prove" the latter hypothesis.\]
This is a single sample study where medical records will be searched by CPT codes for ALIF codes (e.g. 22558, 22585, 22845, etc.) by trained researcher(s) 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 (e.g. 22558, 22585, 22845, etc.) by trained researcher(s) 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:
False
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?: