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?
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 Nichol Mill
Franklin, TN 37067
615-844-1280
Back to top
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.
Back to top
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 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.
Back to top
What is being tested?
A fully synthetic bone graft substitute to facilitate fusion.
Back to top
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 5:1 chance of receiving the
Augment™
Injectable treatment in this study.
Back to top
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.
Back to top
When will I know
if I am eligible?
The study site will determine your eligibility at the time of a
clinic visit.
Back to top
Where is the
study being conducted?
The Augment Injectable clinical study is being conducted at several
clinical centers in North America.
For an up-to-date list of active centers, please visit
www.clinicaltrials.gov
Back to top
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.
Back to top
Can you tell me more
about the study’s goals or objectives?
To evaluate a synthetic bone graft material as a replacement for
autograft in foot and ankle fusion surgery.
The investigational product, Augment Injectable, is intended
to provide equivalent fusion rates to autograft while eliminating
the need for an invasive procedure to harvest the graft.
Back to top
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.
Back to top
|
