Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Columbia Orthopaedic Group, LLP.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
DePuy Spine
Information provided by:
Columbia Orthopaedic Group, LLP
ClinicalTrials.gov Identifier:
NCT00555659
First received: November 7, 2007
Last updated: May 25, 2010
Last verified: November 2007
History of Changes
  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
Degeneration
Spondylosis
Spondylolithesis
Stenosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: September 2007
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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
Sampling Method:   Non-Probability Sample
Study Population

Any person who comes into the clinic and gives consent to participate in this prospective study.

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

Locations
United States, Missouri
Columbia Orthopaedic Group
Columbia, Missouri, United States, 65201
Sponsors and Collaborators
Columbia Orthopaedic Group, LLP
DePuy Spine
Investigators
Principal Investigator: John D Miles, MD Columbia Orthopaedic Group, LLP
  More Information

No publications provided

Responsible Party: Donnamarie Tonnelli, De Puy Spine
ClinicalTrials.gov Identifier: NCT00555659     History of Changes
Other Study ID Numbers: 1094241
Study First Received: November 7, 2007
Last Updated: May 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia Orthopaedic Group, LLP:
Degeneration
Spondylosis
Spondylolisthesis
Stenosis

Additional relevant MeSH terms:
Constriction, Pathologic
Spondylolisthesis
Spondylosis
Pathological Conditions, Anatomical
 Spondylolysis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 21, 2013