AM I A CANDIDATE?
You may be eligible to participate in the hindfoot study if you meet all entry criteria according to the clinical study protocol. If you have been diagnosed by your doctor with a degenerative joint disease requiring joint fusion in the hindfoot due to a congenital deformity, osteoarthritis, rheumatoid arthritis, post traumatic arthritis or ankylosing spondylitis, you may qualify for this study. Each candidate will be pre-screened for study enrollment. If you meet all study criteria you will have a physical exam of the injured hindfoot to determine if the hindfoot area requires a fusion of the subtalar, calcaneocuboid, and/or talonavicular joints. Existing medical history, cause of joint injury and x-rays will be reviewed and evaluated by the orthopedic surgeon to determine if a hindfoot fusion is beneficial for you. How Long is the Clinical Study?All participants will be monitored over a two year period after the hindfoot fusion procedure. Following surgery participants will be asked to return for approximately ten follow-up visits at designated intervals to complete the study. Foot Fact: The 52 bones in your feet make up about one-fourth of all the bones in your body. The Hindfoot Fusion Procedure with Augment® Injectable Bone GraftHindfoot fusion is a surgical technique called arthrodesis. This is done to relieve pain that cannot be managed by medication, splints, or other treatments. After cleaning and prepping the joint space, the surgeon will make an incision on the outside of the surgical site to gain access to the hindfoot, located in the rearfoot area. The surgical team then removes the cartilage from the affected joint to allow the bones to come into direct contact. Either Augment Injectable Bone Graft (the investigational bone grafting material) or autograft (your own bone) will then be placed into the fusion site and directly onto the entire surface area of the joints to be fused. All defects and spaces between the joints in the area will be filled with Augment Injectable Bone Graft or autograft. The appropriate joints will then be properly aligned and stabilized with pins and screws to compress the hindfoot joints. The fixation devices and bone grafting material are intended to keep the joint stable until a fusion can take place. This clinical study will evaluate a new bone grafting material, Augment Injectable Bone Graft, the investigational device, for use in a standard fusion procedure. The study is being conducted to see whether Augment® Injectable Bone Graft is a safe and effective alternative for autograft in foot and ankle bone fusions. Only the physician or clinical research coordinator can determine if you are eligible to participate in the clinical study. For a list of Foot Fusion clinical studies in your area please visit www.clinicaltrials.gov View Surgical Procedure |
