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

N/AActive Not RecruitingNCT05945550

Methodist Health System3,500 enrolled

Overview

To identify the current mortality rate for initial Anterior Lumbar Interbody Fusion(ALIF)procedures. Establish/prove mortality rates for this operation have dropped in the past decade.

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 Current Procedural Terminology(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 Type

OBSERVATIONAL

Enrollment

3,500

Conditions

Lumbar Spondylolisthesis Lumbar Spine Degeneration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Methodist Dallas Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Establish/prove mortality rates

Establish mortality rates of patients for this operation have dropped in the past decade.

Time frame: 5 years

Secondary Outcomes

Establish the mortality rate for "re-do" ALIF procedures [

Establish the patient's mortality rate, postulate that there are interventions that can be done in the pre-operative period to ameliorate that risk.

Time frame: 5 years

Data from ClinicalTrials.gov

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