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

This study has been completed.
Sponsor:
Collaborator:
DePuy Spine
Information provided by (Responsible Party):
John Miles, MD, Columbia Orthopaedic Group, LLP
ClinicalTrials.gov Identifier:
NCT00555659
First received: November 7, 2007
Last updated: August 8, 2013
Last verified: August 2013
  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 ]

Enrollment: 104
Study Start Date: September 2007
Study Completion Date: February 2013
Primary Completion Date: February 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: John Miles, MD, Investigator, Columbia Orthopaedic Group, LLP
ClinicalTrials.gov Identifier: NCT00555659     History of Changes
Other Study ID Numbers: 1094241
Study First Received: November 7, 2007
Last Updated: August 8, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Spondylolisthesis
Spondylosis
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylolysis

ClinicalTrials.gov processed this record on November 24, 2014