Foot and Ankle Fusion
The foot and ankle are a complex of 26 bones and joints that must work in concert to enable pain free ambulation and movement. In some individuals, either from traumatic injury or due to the degenerative effects of arthritis, motion at one or more of these joints becomes painful.
Initial treatment for this type of pain is conservative (e.g. pain medications, bracing, rest), however in patients where these measures are no longer effective, fusion surgery is often recommended to alleviate pain.
In fusion surgery, the cartilage of the affected joint(s) is removed and metallic plates and/or screws (hardware) are applied to rigidly fix the bones together. This approach eliminates the motion and consequently the pain associated with the movement of the affected joint. In contrast to joints like the shoulder, hip and knee, the normal range of motion in the foot is limited, therefore fusion surgery is generally well-tolerated. In the United States approximately 100,000 patients undergo this procedure annually.
Augment® Bone Graft has been developed as a bioengineered replacement
Successful fusion surgery requires new bone to bridge the area previously occupied by the joint space. To enable this process, orthopedic surgeons often will take bone from another part of the body (e.g. hip, shin, heel) and use it to fill the joint. Harvested bone, known as autograft, is considered by orthopedic surgeons to be the most reliable enhancer of bone healing.
Despite the advantages of the autograft, there are a significant number of disadvantages, including the need to perform a second surgery, additional operative time and/or resources, the potential for post-operative complications and long-term pain at the graft site. Further, the quality of autograft, in terms of its ability to facilitate bone regeneration is believed to be diminished in the elderly, in smokers and in patients with systemic diseases such as diabetes and osteoporosis. These factors establish a need for an off-the-shelf, potent and reliable alternative to autograft in these patients.
Augment Bone Graft is approved for sale in Canada and Australia. It is not available for sale in the United States. For many parts of the world, including the EU, BioMimetic is developing Augment for broader indications. The proposed EU indication for Augment and Augment Injectable Bone Grafts includes their use in bony procedures that require supplemental graft material for the repair and regeneration.