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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00555659
Acronym
Aegis
Enrollment
104
Registered
2007-11-09
Start date
2007-09-30
Completion date
2013-02-28
Last updated
2013-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degeneration, Spondylolithesis, Spondylosis, Stenosis

Keywords

Degeneration, Spondylosis, Spondylolisthesis, Stenosis

Brief 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.

Interventions

None listed

Sponsors

DePuy Spine
CollaboratorINDUSTRY
Columbia Orthopaedic Group, LLP
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Standard of care

Exclusion criteria

* Standard of care

Design outcomes

Primary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026