Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody Fusions - Full Text View

Sponsors and Collaborators:	Columbia Orthopaedic Group, LLP DePuy Spine
Information provided by:	Columbia Orthopaedic Group, LLP
ClinicalTrials.gov Identifier:	NCT00555659

Purpose

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	Intervention
Degeneration Spondylosis Spondylolithesis Stenosis	Procedure: Anterior Lumbar Interbody Fusion

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody

Further study details as provided by Columbia Orthopaedic Group, LLP:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2009

Arms	Assigned Interventions
A	Procedure: Anterior Lumbar Interbody Fusion Anterior Lumbar Interbody Fusion Performed at One Level

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Standard of care

Exclusion Criteria:

Standard of care

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555659

Contacts

Contact: John Miles, MD

573-875-8844

j.miles@columbiaorthogroup.com

Locations

United States, Missouri
Columbia Orthopaedic Group	Recruiting
Columbia, Missouri, United States, 65201
Contact: James A Ronan 573-875-8844 j.ronan@columbiaorthogroup.com
Principal Investigator: John Miles, MD
Sub-Investigator: Dennis Abernathy, MD
Sub-Investigator: Robert Gaines, MD

Sponsors and Collaborators

Columbia Orthopaedic Group, LLP

DePuy Spine

Investigators

Principal Investigator:

John D Miles, MD

Columbia Orthopaedic Group, LLP

More Information

Study ID Numbers:	1094241
Study First Received:	November 7, 2007
Last Updated:	November 7, 2007
ClinicalTrials.gov Identifier:	NCT00555659
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia Orthopaedic Group, LLP:

Degeneration
Spondylosis
Spondylolisthesis
Stenosis

Study placed in the following topic categories:

Spinal Diseases
Musculoskeletal Diseases
Constriction, Pathologic
Spondylolisthesis
Bone Diseases

ClinicalTrials.gov processed this record on January 15, 2009