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CTSI is now on Facebook!
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Currently Enrolling
- eXtreme Lateral Total Disc Replacement
- Facet Replacement
- CoFlex
- Bone Marrow Aspirate Concentrate
- Lateral Interbody Fusion
- Mesoblast Stem Cell Fusion
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Leading Edge
- XLIF
- Kyphoplasty
- ProDisc
- Stem Cells
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Randall F. Dryer, M.D., of the Central Texas Spine Institute, is a principal
investigator for this multi-center clinical trial to evaluate the Anatomic Facet
Replacement System (AFRS™) for the treatment
of back and leg pain due to lumbar spinal stenosis. Central Texas Spine
Institute is now enrolling candidates for this study.
Although spinal fusion is well accepted as the standard of
care for lumbar spinal stenosis and related spinal instability, it is associated
with a loss of natural motion at the treated area, which may accelerate adjacent
segment degeneration. Facet Joint Replacement has been developed to
provide symptom relief from lumbar spinal stenosis while preserving natural
motion at the treated area.
Patient Eligibility Summary
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Age 21 to 85
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Diagnosis of lumbar spinal stenosis at up to 3 levels from L3
to S1, requiring facet replacement at a single L4-L5 level
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Failure to respond to at least 6-months of non-operative, conservative management
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Surgical candidate for decompression with facetectomy and fusion
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Has not had 2 or more surgeries at the operative level
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Does not have osteoporosis
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Predominantly afflicted with leg pain
All potential candidates are subject to
the above and additional non-listed clinical trial criteria. If
you are interested in being considered a candidate for the AFRS™ clinical trial, please
visit www.stenosisrelief.com
or contact our study
coordinator, Amy, via email at
studyinfo@pqrinc.com.
Caution:
Investigational device, limited by Federal law to investigational use.
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Randall F. Dryer, M.D., of Central
Texas Spine Institute, is a principal investigator for this
prospective, randomized, controlled multi-center clinical trial to
valuate the safety and effectiveness of the Coflex
in treating spinal stenosis.
 The Paradigm Spine Coflex® device is designed to treat spinal stenosis at 1 or 2 contiguous levels of the spine from L1 to L5. Stenosis, for purposes of this study, is defined as a >25% reduction of an anterio-posterior dimension compared to the next adjacent level of the spine.
To be considered a candidate for this study, your back pain must be at least a 50 on the VAS scale and you must have undergone at least 6 months of conservative treatment. Additionally you must be between the ages of 40 and 80.
The control group for this study will undergo a laminectomy with posterlateral fusion using either the Medtronic CD Horizon or the DePuy Spine Expedium pedicle screw system and autograft bone.
All potential candidates are subject to the above and additional non-listed clinical trial criteria. If you are interested in being considered a candidate for the Coflex® clinical trial, please visit
www.coflexspinestudy.com or contact our study coordinator, Amy, via email at
studyinfo@pqrinc.com.
Caution:
Investigational device, limited by Federal law to investigational use.
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