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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2013-02-28

Brief Summary

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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

Detailed Description

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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.

Conditions

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Degeneration Spondylosis Spondylolithesis Stenosis

Keywords

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Degeneration Spondylosis Spondylolisthesis Stenosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Standard of care

Exclusion Criteria

* Standard of care

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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John Miles, MD

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John D Miles, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia Orthopaedic Group, LLP

Locations

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Columbia Orthopaedic Group

Columbia, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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1094241

Identifier Type: -

Identifier Source: org_study_id