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

Sponsor
Methodist Health System (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05945550
Collaborator
(none)
3,500
Enrollment
1
Location
48
Anticipated Duration (Months)
72.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To identify the current mortality rate for initial ALIF procedures. Establish/prove mortality rates for this operation have dropped in the past decade.

Condition or Disease Intervention/Treatment Phase

    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 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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3500 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Retrospective
    Official Title:
    Comparison of Complication Rates Between Initial and Re-operative Anterior Lumbar Interbody Fusion Surgery: Is There a Difference?
    Actual Study Start Date :
    Dec 28, 2020
    Anticipated Primary Completion Date :
    Dec 28, 2024
    Anticipated Study Completion Date :
    Dec 28, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Establish/prove mortality rates [5 years]

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

    Secondary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Methodist Dallas Medical Center Dallas Texas United States 75203

    Sponsors and Collaborators

    • Methodist Health System

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Methodist Health System
    ClinicalTrials.gov Identifier:
    NCT05945550
    Other Study ID Numbers:
    • 038.SUR.2020.A
    First Posted:
    Jul 14, 2023
    Last Update Posted:
    Jul 14, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 14, 2023