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

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

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Key information

Conditions

Degeneration Bone Diseases Constriction, Pathologic Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases Spondylolisthesis Spondylolithesis Spondylolysis Spondylosis Stenosis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia Orthopaedic Group

Columbia, Missouri, 65201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Standard of care

Exclusion criteria

Standard of care

Treatment and study plan

Primary outcomes

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

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Columbia Orthopaedic Group, LLP

Other

Collaborators

DePuy Spine

Registry information

Official study title

Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody

Acronym: Aegis

Important dates

Study start: 2007
Primary completion: 2013
Study completion: 2013
First posted: Nov 9, 2007
Registry last updated: Aug 12, 2013

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.

Published trials that share one or more normalized conditions with this study.

Completed