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

Methodist Health System

Status: Active, not recruiting

Conditions: Lumbar Spine Degeneration; Lumbar Spondylolisthesis

Study type: Observational

Funder types: Other

Identifiers

NCT05945550

038.SUR.2020.A

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 3,500 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.