FAQs
Who is sponsoring this
study?
Is there a cost associated
with participating in this study?
If I participate, how
many times do I have to go back to the doctor's office and how
long is the study?
What is being tested?
Is there a “control”
group in this study? Can I request the group in which I want
to be placed?
Will the device cause
temporary or long-term side effects?
When will I know
if I am eligible?
Where is the study
being conducted in my area?
How will my medical
information be kept confidential?
Can you tell me more
about the study’s goals or objectives?
What if I get in the
study and I decide I do not want to participate anymore? Can
I drop out?
Who is sponsoring this study?
BioMimetic Therapeutics, Inc
389-A Nichol Mill Lane
Franklin, TN 37067
615-844-1280
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Is there a cost associated with
participating in this study?
There will be no added costs to you for participating in this
study. You will still be billed for any payments that
may be required by your health insurance plan. When you are no
longer participating in this study, you will be billed for
all costs of your medical care.
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If I participate, how many
times do I have to go back to the doctor's office and how long
is the study?
There are regularly scheduled telephone and clinic visits throughout
the study period. Most of these are standard follow-up visits
for general foot and ankle surgery. There are 10 study visits
over a period of one (1) year following surgery.
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What is being tested?
A fully synthetic bone graft material to facilitate fusion.
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Is there a “control”
group in this study? Can I request the group in which I want to
be placed?
The control for this study is ABG (Autologous Bone Graft - harvested
from your hip or leg). No participant can choose in which group
he or she will be placed. That decision is random, like the flip
of a coin. If you are eligible to participate and are accepted
into the study, you will have a 2:1 chance of receiving the
GEM OS®1 treatment in this study.
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Will the device cause
temporary or long-term side effects?
Your study physician will discuss any potential risks/side effects
of the investigational device and surgery prior to your enrollment
in this study.
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When will I know
if I am eligible?
If you meet the initial prescreening criteria (that is; completing
the call center survey), and have given your permission to provide
your contact information to the research site in your area, the
study site will be able to determine your eligibility.
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Where is the
study being conducted in my area?
There might be a research study site near you. Before giving information
to the study site that is participating in the clinical research
study, you need to complete the phone questionnaire to see if you
meet the initial prescreening criteria of the study.
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How will my medical
information be kept confidential?
The information gathered in this study may also be used in research
and development projects designed to investigate approaches diagnosing
and treating diseases. Your identity will never be disclosed in
connection with these research and developments. Your information
may also be used in articles intended for publication in scientific
journals and in scientific meetings; however, no publication or
presentation at a scientific meeting about the research will reveal
your identity without your specific written permission, unless
required by law. These limitations continue even if you revoke
(take back) your authorization.
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Can you tell me more
about the study’s goals or objectives?
To evaluate a bone graft material comprised of a protein that
is found naturally in your body and a synthetic bone material to
facilitate fusion in conditions or injuries requiring bone graft
in a representative clinical fusion model and thus the opportunity
to provide equivalent union rates as ABG without necessitating
an additional invasive procedure to harvest the graft.
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What if I get in the study
and I decide I do not want to participate anymore? Can I
drop out?
If you decide you do not want to be in
this study your decision will not affect your medical care or affect
your relationship with any of your doctors.
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If you or someone you know has been diagnosed with a hindfoot or ankle condition
that may require fusion or If you have questions regarding the Foot and Ankle Fusion
Study, or would like information regarding clinical trial site locations in your
area,
please contact us.
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