NCT00555659

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

Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 104 (actual)
• Sponsor: Columbia Orthopaedic Group, LLP · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Degeneration
• Spondylosis
• Spondylolithesis
• Stenosis

Timeline

• Start date: 2007-09-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2007-11-09
• Last updated: 2013-08-12

Locations

1 site across 1 country: United States