PATIENT FAQS

Additional Links Clinical Trial Overview About Augment Injectable Bone Graft Hindfoot Anatomy Am I a Candidate? Glossary Patient FAQs

Who is sponsoring this study?
BioMimetic Therapeutics, Inc
389 Nichol Mill Lane
Franklin, TN 37067
615-844-1280

Is there a cost associated with participating in this study?
There are no costs to you for participating in this study. You will be billed for any payments that may be required by your health insurance plan.

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 after surgery.

There are approximately 10 follow-up visits over a period of two (2) years following the hindfoot fusion surgery.

What is being tested?
Augment® Injectable Bone Graft. A fully synthetic bone graft substitute to help promote bone formation and facilitate fusion.

Is there a “control” group in this study? Can I request which group I would like to be placed?
Yes. The control group, participants randomly selected for standard fusion treatment, for this study is Autologous Bone Graft (ABG). ABG is harvested bone graft from your hip or leg. Study participants can not choose which study group he or she would like to be placed. Participants are randomly chosen which treatment you will receive.

If you are eligible to participate and are accepted into the study, you will have a 2:1 chance of receiving the Augment® Injectable Bone Graft treatment in this study.

Will the investigational device cause temporary or long-term side effects?
Your study physician will discuss any potential risks or side effects you may experience from the investigational device prior to your enrollment in this study.

When will I know if I am eligible?
The clinical research site will determine your eligibility during the initial screening visit.

Where is the study being conducted?
The Augment® Injectable Bone Graft 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

How will my medical information be kept confidential?
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule establishes how your personal health information (PHI) may be used for clinical research studies.

Prior to any screening tests and evaluations or study enrollment you will be asked to sign an Informed Consent Form (ICF) giving permission to allow disclosure of your PHI for the clinical research study. The ICF explains how personal confidential information of a study participant’s records will be maintained and the possible inspection of those records by government agencies.

Data gathered in this study may 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 development projects.

Clinical data may be used in articles intended for publication in scientific journals and in scientific meetings; however, no publication or presentation will reveal your identity without your specific written permission, unless required by law. These limitations continue even if you withdraw from the study.

Can you tell me more about the study’s goals or objectives?
To evaluate a synthetic bone graft material as an alternative for autograft in hindfoot fusion surgery. The investigational product, Augment® Injectable Bone Graft, is intended to provide equivalent fusion rates to autograft while eliminating the need for an invasive procedure to harvest the graft.

What if I decide not to participate in the study?  Can I drop out?
As a volunteer it’s your decision to participate in the clinical study. If you decide this study is not appropriate, you may withdraw at anytime for any reason.