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Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody Fusions

Sponsor
Columbia Orthopaedic Group, LLP (Other)
Overall Status
Completed
CT.gov ID
NCT00555659
Collaborator
DePuy Spine (Industry)
104
Enrollment
1
Location
65.1
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Introduction: Degenerative changes of the discs and facet joints in the lumbar spine can result in pain and disability from spondylosis, spondylolisthesis and stenosis. Patients who are suffering with back and/or leg pain are potential candidates for an ALIF procedure.

Purpose: To assess and compare clinical outcomes and fusion rates in patients undergoing an instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic categories. Comparisons between type of interbody spacer, graft type, and type of instrumentation will also be made

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To assess and compare clinical outcomes and fusion rates in patients undergoing an instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic categories. Comparisons between type of interbody spacer, graft type, and type of instrumentation will also be made.

    This study is part of a larger Continuous Quality Improvement initiative at the Columbia Orthopaedic Group. The purpose of this effort is to improve surgical and non-surgical outcomes by using rigorous statistical analysis of our outcomes to guide our treatment decisions. Through an iterative feedback process we hope to optimize patient outcomes.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    104 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody
    Study Start Date :
    Sep 1, 2007
    Actual Primary Completion Date :
    Feb 1, 2013
    Actual Study Completion Date :
    Feb 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Intake data will include all fields traditionally associated with a detailed note. Subsequent visit instruments will include visual analog scale and oswestry disability index. [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Standard of care
    Exclusion Criteria:
    • Standard of care

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Columbia Orthopaedic Group Columbia Missouri United States 65201

    Sponsors and Collaborators

    • Columbia Orthopaedic Group, LLP
    • DePuy Spine

    Investigators

    • Principal Investigator: John D Miles, MD, Columbia Orthopaedic Group, LLP

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    John Miles, MD, Investigator, Columbia Orthopaedic Group, LLP
    ClinicalTrials.gov Identifier:
    NCT00555659
    Other Study ID Numbers:
    • 1094241
    First Posted:
    Nov 9, 2007
    Last Update Posted:
    Aug 12, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by John Miles, MD, Investigator, Columbia Orthopaedic Group, LLP
    Degeneration
    Spondylosis
    Spondylolisthesis
    Stenosis
    Additional relevant MeSH terms:
    Spondylosis

    Study Results

    No Results Posted as of Aug 12, 2013