DegenerationAegisNCT00555659
Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody Fusions
An observational study of Degeneration and Spondylosis, run by Columbia Orthopaedic Group, LLP at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Degeneration, Spondylosis, Spondylolithesis
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any person who comes into the clinic and gives consent to participate in this prospective study.
Who may be able to join
- Standard of care
Who cannot join
- Standard of care
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia Orthopaedic Group
Columbia, Missouri, 65201
About this study
Official title: Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody
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
Read the 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
- Keywords
- Degeneration, Spondylosis, Spondylolisthesis, Stenosis
- Medical subject headings
- Spondylosis, Spondylolisthesis, Constriction, Pathologic
What is being measured
The primary outcome is the main question the study is designed to answer.
Intake data will include all fields traditionally associated with a detailed note. Subsequent visit instruments will include visual analog scale and oswestry disability index.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia Orthopaedic Group, LLP
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Spine
- Responsible party
- Principal investigator, John Miles, MD, Columbia Orthopaedic Group, LLP
- Investigators
- John D Miles, MD, Principal investigator, Columbia Orthopaedic Group, LLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555659
- Sponsor's protocol ID
- 1094241
- Acronym
- Aegis
- Status last verified
- Aug 2013
- First submitted
- 7 Nov 2007
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody
- ClinicalTrials.gov ID
- NCT00555659
- Acronym / sponsor ID
- Aegis / 1094241
- Conditions
- Degeneration, Spondylosis, Spondylolithesis, Stenosis
- Keywords
- Degeneration, Spondylosis, Spondylolisthesis, Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Columbia Orthopaedic Group, LLPUniversity, hospital or other
- Collaborators
- DePuy Spine
- Study start
- Sep 2007
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 9 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any person who comes into the clinic and gives consent to participate in this prospective study.
Key inclusion criteria (1 listed)
- Standard of care
Key exclusion criteria (1 listed)
- Standard of care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D Miles, MD principal investigator
Columbia Orthopaedic Group, LLP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degeneration and Spondylosis, run by Columbia Orthopaedic Group, LLP at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.