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

March 18, 2026 updated by: Methodist Health System
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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Methodist Dallas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Reed Donald, MD, Methodist Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2020

Primary Completion (Estimated)

December 28, 2027

Study Completion (Estimated)

December 28, 2028

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 038.SUR.2020.A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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