Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a Difference?

Active, not recruiting

• Conditions: Lumbar Spondylolisthesis; Lumbar Spine Degeneration

• Registration Number: NCT05945550
• Lead Sponsor: Methodist Health System

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.

Study Timeline

• Study Start: 2020-12-28
• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-15
• Primary Completion: 2024-12-28
• Study Completion: 2024-12-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3500

Inclusion Criteria

• Patients > 17 years of age, patients having had ALIF procedures as defined by CPT codes at participating Methodist facilities during 2010-2020 targeted.

Exclusion Criteria

• Pediatric patients (as defined by age <18 years old), pregnant women and incarcerated individuals. We do not anticipate any of these in an elective spine surgery group of patients. If they have emergency spine surgery it is normally not an ALIF.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establish/prove mortality rates	5 years	Establish mortality rates of patients for this operation have dropped in the past decade.

Secondary Outcome Measures

Name	Time	Method
Establish the mortality rate for "re-do" ALIF procedures [	5 years	Establish the patient's mortality rate, postulate that there are interventions that can be done in the pre-operative period to ameliorate that risk.

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States