FAQs
Who is the sponsor?
Who is the lead
investigator(s)?
What is the purpose of
the study?
Are patients to be
randomized? How?
What is the intended
use for the device?
Where is the study
taking place?
What is the size
and duration of the study?
Who can I
contact for more information on the study?
What
are the key Inclusions and Exclusions for the study?
Who is the sponsor?
BioMimetic Therapeutics, Inc.
389-A Nichol Mill Lane
Franklin, TN 37067
615-844-1280
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Who is the lead
investigator(s)?
Dr. Christopher DiGiovanni (Providence, RI)
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What is the purpose of the
study?
To evaluate the safety and effectiveness of a fully synthetic
bone graft 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. It is a randomized, controlled, multi-center pivotal
clinical trial. The study is designed to determine if GEM OS®1 demonstrates
equivalent clinical and radiologic outcomes compared to the “gold
standard” (ABG) in a representative clinical model (foot and ankle
fusions).
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Are patients to be randomized?
How?
Treatment Groups:
Group I: Standard Rigid Fixation + ABG
Group II: Standard Rigid Fixation + GEM OS1
Patients will be randomized in a 2:1 ratio (GEM OS1 :
Autograft)
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What is the intended
use for the device?
Indications are for male and female patients over the age of 18
years of age requiring a hindfoot or ankle fusion procedure involving
a bone grafting procedure.
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Where
is the study taking place?
There will be up to 35 facilities taking part in the study.
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What is the size
and duration of the study?
The study will enroll up to 396 patients presenting a defect
requiring fusion in the hindfoot or ankle. Duration of study: 12
months follow-up post-randomization.
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Who
can I contact for more information on the study?
For more information, you can go to the web site http://www.biomimetics.com.
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What
are the key Inclusions and Exclusions for the study?
Inclusion Criteria
1) The patient has a bone defect in the hindfoot or ankle
requiring fusion using open surgical technique with supplemental
bone graft/substitute, requiring one of the following procedures:
- Ankle joint fusion
- Subtalar fusion
- Calcaneocuboid fusion
- Talonavicular fusion
- Triple arthrodesis (subtalar, talonavicular and calcaneocuboid
joints)
- Double fusions (talonavicular and calcaneocuboid joints)
2) The fusion site is able to be rigidly stabilized with
no more than three (3) screws across the fusion site. Supplemental
pins may be used. Supplemental screws external to the fusion site(s)
are also allowed. Plate fixation is not part of the study protocol
and is excluded.
3) The patient is at least 18 years of age and considered
to be skeletally mature.
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Exclusion Criteria
1) The patient has undergone previous surgery of the proposed
fusion site.
2) The fusion site requires plate fixation, more than three
(3) screws across the fusion site to achieve rigid fixation, or
more than three (3) kits, or 9cc of graft material.
3) The patient currently has detectable untreated cancer
(other than basal cell carcinoma) or is currently undergoing radio-
or chemotherapy.
4) The patient has a pre-existing sensory impairment (e.g.
diabetics with baseline sensory impairment) which limits the ability
to perform objective functional measurements and may place patients
at risk for complications. For the purpose of this protocol, diabetics
that are not sensitive to the 5.07 monofilament (Semmes-Weinstein)
are to be excluded.
5) The patient is pregnant or a female intending to become
pregnant during this study period. A urine pregnancy test will
be administered within 21 days of the surgical visit to any female
unless she is post-menopausal, has been sterilized or is practicing
a medically-accepted method of contraception.
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If you have any questions or feel you have patients who may
benefit from this study, call 1-615-844-1280 or please contact us.
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