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OpenTrials
Active, Not Recruiting

NCT Number: NCT05945550

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Lumbar Spondylolisthesis Bone Diseases Lumbar Spine Degeneration Musculoskeletal Diseases Spinal Diseases Spondylolisthesis Spondylolysis Spondylosis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Establish/prove mortality rates

    Time frame: 5 years

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

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Jul 14, 2023
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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