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What is lumbar spinal stenosis?
What is the coflex® investigational
device and how does it work?
Are clinical research studies safe?
Are
there any costs for participating in the coflex spine
clinical research trial?
How do I know if I’m
eligible to participate in the study?
What is lumbar spinal stenosis?
Spinal stenosis is a narrowing of the spinal canal. The pain (as
well as the numbness, weakness, tingling or burning sensations)
from lumbar spinal stenosis is caused by the pressure applied to
nerves in the spine due to spine canal narrowing. As we age, and
because of wear and tear, our spines can become a bit unstable.
The supporting ligaments of the spine thicken (hypertrophy) and
harden (calcification). Bone spurs (osteophytes) may also form.
Spondylolisthesis (the slipping of one vertebra onto another) can
also occur, leading to compression and/or inflammation of the nerve
roots. The body’s attempt to compensate for the destabilization
of the spine also contributes another source of spinal stenosis
pain.
What is the coflex® investigational
device
and how does it work?
The coflex device is an implant designed to be surgically placed
between the spinous processes (the part of the spine extending from
the back of the spine, which can frequently be felt through the
skin along the center of the back) following decompression. Once
implanted, the coflex is intended to increase the space in the spinal
canal by restoring the distance between the vertebrae and creating
larger openings through which the nerve roots can pass, thereby
helping to mitigate the symptoms of lumbar spinal stenosis, including
the pain, weakness and other abnormal sensations.
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Are clinical research studies safe?
Before participating in a clinical research study, a patient must
agree to sign an Informed Consent, which provides detailed information
about the safety of the study and procedures. For more information
on clinical research studies, please visit www.clinicaltrials.gov/ct/info.
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Are there any costs for participating in
the
coflex spine clinical research trial?
There are no added costs to you for participating in this study.
You will be responsible for any co-payments or other cost-sharing
payments that may be required by your health insurance plan. Once
you are no longer participating in this study, you will be responsible
for all costs of your medical care.
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How do I know if I’m eligible to participate
in the study?
Your first step is to take the online
questionnaire, which is the
first step in determining your eligibility. Should you meet the
initial set of criteria, you will be directed to fill out your contact
information, or you may call the toll-free, nurse-staffed information
line directly at 1-866-493-9510. Because of the
strict regulations regarding participation in clinical research
studies, only a clinical research staff member can determine your
eligibility.
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For more information
on the coflex clinical research study, or to see if you might be
eligible to participate, call 1-866-493-9510 Mon–Thurs,
7am– 7pm and Fri, 7am– 6pm, CST.
CAUTION:
Investigational device.Limited by Federal (or United States) law
to investigational use.
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