Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody Fusions (Aegis)
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|ClinicalTrials.gov Identifier: NCT00555659|
Recruitment Status : Completed
First Posted : November 9, 2007
Last Update Posted : August 12, 2013
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|
|Degeneration Spondylosis Spondylolithesis Stenosis|
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 Type :||Observational|
|Actual Enrollment :||104 participants|
|Official Title:||Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555659
|United States, Missouri|
|Columbia Orthopaedic Group|
|Columbia, Missouri, United States, 65201|
|Principal Investigator:||John D Miles, MD||Columbia Orthopaedic Group, LLP|