ABOUT AUGMENT INJECTABLE BONE GRAFT

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

In many foot and ankle fusion surgeries, bone has to be harvested from another area of your body (such as the hip, knee, shin or heel) to enhance bone healing at the primary fusion site. Harvested bone, known as autograft, has been successfully used in orthopedic surgery for decades. However, the use of autograft has some significant drawbacks, including the risk of post-operative pain or infections at the harvest site, and the potential for increased operative time.

The investigational device, Augment® Injectable Bone Graft, has been designed as an alternative to autograft eliminating the need for a second surgical procedure.

What is Augment Injectable Bone Graft?

Augment Injectable Bone Graft is a bone substitute that is composed of two separate components which promote bone regeneration. One component (Beta TCP) is similar to our own body’s natural bone mineral content. The second component is a synthetic protein called recombinant human platelet-derived growth factor-BB (rhPDGF-BB).

β-TCP, a synthetic bone scaffold, is a material similar to the natural bone mineral found in our body. β-TCP has been used for surgical implant applications for many years to enhance the bone healing process. β-TCP physically fills the bone void to prevent the collapse of soft tissue into the bone defect, and provides a framework to support new bone formation.

The second material, highly purified recombinant human PDGF-BB, is a naturally occurring growth factor that is released as a normal response to injury. PDGF-BB initiates the body’s natural healing response. PDGF-BB stimulates recruitment and proliferation of cells involved in healing.

In addition to recruiting cells involved in healing, PDGF works to stimulate formation of new blood vessels. As in the case of PDGF release resulting from the normal tissue repair response, rhPDGF-BB is cleared from the body during circulation and eliminated by the kidneys after it has been broken down.

How Can I Participate in this Clinical Study?

If you have been diagnosed by your doctor with a degenerative joint disease of the hindfoot and require joint fusion due to a congenital deformity, osteoarthritis, rheumatoid arthritis, post traumatic arthritis or ankylosing spondylitis, you may qualify.