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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05945550

Enrollment

3500

Registered

2023-07-14

Start date

2020-12-28

Completion date

2028-12-28

Last updated

2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spine Degeneration, Lumbar Spondylolisthesis

Brief summary

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.

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 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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORReed Donald, MD

Methodist Health System

Outcome results