A Biomechanical Assessment of the AST Stabilimax BAR Using Radiostereometric Analysis (RSA)
Withdrawn before enrolling
Conditions studied: Assess Motion in Flexion/Extension and Lateral Bending of the Lumbar Vertebrae in Vivo Following Motion Sparing Surgery Using Radiostereometric Analysis (RSA.)
In brief
Assessment of segmental spine motion has been and continues to be, a difficult clinical problem. Errors of up to 10 degrees for simple measurements of flexion, extension and side bending have been recorded using conventional radiographs (xrays.) These errors are usually associated with the inability to acquire three-dimensional positions and inaccurate reference points. It has, therefore, been extremely difficult to measure small changes in vertebral alignment, which may prove to be an early, clinically significant, indicator of potential problems. 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. 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. 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 of the implanted construct. 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?
Key facts
- Study ID
- NCT00634465
- Run by
- State University of New York - Upstate Medical University
- People needed
- 0
- Starts
- 2006-10-01
- Expected to finish
- 2008-10-01
- Last updated by the study team
- 2015-05-25
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects scheduled to have lumbar surgery to receive the AST Stabilimax BAR
- All subjects must be skeletally mature, between the ages of 18-75
You may not qualify if…
- Pregnant women will be excluded due to added radiation exposure
- Prisoners will also be excluded
Where it is running
- SUNY Upstate Medical University — Syracuse, New York, United States
Full record on ClinicalTrials.gov
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