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NCT00555659 Clinical Trial

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

Stenosis Clinical Trial

— Aegis  

Official title:
Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00555659
Other study ID # 1094241
Secondary ID
Status Completed
Phase N/A
First received November 7, 2007
Last updated August 8, 2013
Start date September 2007
Est. completion date February 2013

Study information
Verified date August 2013
Source Columbia Orthopaedic Group, LLP
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Standard of care

Exclusion Criteria:

- Standard of care

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Columbia Orthopaedic Group Columbia Missouri

Sponsors (2)
Lead Sponsor Collaborator
Columbia Orthopaedic Group, LLP DePuy Spine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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