- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00634465
A Biomechanical Assessment of the AST Stabilimax BAR Using Radiostereometric Analysis (RSA)
Study Overview
Status
Intervention / Treatment
Detailed Description
Radiostereometric Analysis, or RSA, is an accurate in vivo measurement technique using two simultaneous radiographs. It provides researchers with three dimensional motion analyses to look not only at routine flexion/extension, but also other rotational and translational changes. The measurement accuracy offered by this technique far exceeds the manual techniques currently used. Utilization of the RSA technology at the IHP and the United States is in its infancy. The investigators have placed much effort over the past 2-3 years to put the necessary dedicated resources and personnel in place. This has been a collaborative effort between the Department of Orthopedic Surgery and the Imaging Core at IHP. Preliminary work on the accuracy, reliability, and surgical planning for use of RSA has been completed and presented at national conferences.
The purpose of this study is to assess the amount of motion in the lumbar spine in patients with the AST Stabilimax BAR. The AST Stabilimax BAR is designed to allow for motion in the spine while providing the necessary stability to the spinal segment. The amount and degree of this motion is currently unknown clinically, but has been biomechanically tested in vitro. By using tantalum bead markers placed in the spine at the time of the surgery, RSA analysis can determine the amount and degree of motion the implant provides. Two questions will be examined with this data: 1) what is the amount of sagittal and coronal plane motion that occurs in vivo with the AST Stabilimax BAR system? and 2) will this change over the 2 year time frame for this study?
Study Type
Contacts and Locations
Study Locations
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New York
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Syracuse, New York, United States, 13202
- SUNY Upstate Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects scheduled to have lumbar surgery to receive the AST Stabilimax BAR
- All subjects must be skeletally mature, between the ages of 18-75
Exclusion Criteria:
- Pregnant women will be excluded due to added radiation exposure
- Prisoners will also be excluded
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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1
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Radiostereometric Analysis, or RSA, is an accurate in vivo measurement technique using two simultaneous radiographs.
It provides researchers with three dimensional motion analyses to look not only at routine flexion/extension, but also other rotational and translational changes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Stabilimax Bar
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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