A Study Evaluating Amplex Compared To Autograft Bone In Foot and Ankle Fusion Surgery

Inclusion Criteria: * Indicated for foot and ankle surgery described as either a single, double or triple arthrodesis of the ankle, subtalar, calcaneocuboid or talonavicular joints. * Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol * Have the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI) * Be a skeletally mature male or a non-pregnant, non-lactating female at least 18 years of age but not older than age 75 * If a woman is of childbearing potential (not amenorrheic for the previous 24 months or not surgically sterile), then she must: * Have a confirmed negative urine pregnancy test result prior to surgery and the administration of the study product * Agree to use a medically approved method of contraception for the duration of the initial follow-up period of the study * Agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen * Have not been sufficiently responsive to an adequate trial of non-operative treatment (e.g. modified activity, analgesics, anti-inflammatories, bracing, orthotics, physiotherapy, vitamin supplements, or injections etc. prior to study enrollment). Exclusion Criteria: * Has a large bone deficit requiring a structural graft * Charcot joints from neuropathic destruction. * Previous fusion or osteotomy of the proposed site * Requ…