SPECT/CT

Inclusion Criteria:

• Consent for ankle arthrodesis for surgical treatment of end stage ankle arthritis diagnosed by history, physical exam diagnostic imaging.
• 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:
  • 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 enrolment)

Exclusion Criteria:

• Has a large bone deficit requiring a structural graft
• Charcot joints from neuropathic destruction.
• Previous fusion or osteotomy of the proposed site
• Requires osteotomy or fusion of the midfoot joints
• Morbidly obese (BMI >45 kg/m²)
• Women planning to become pregnant during the first year (12 months) following the procedure
• Female subjects of childbearing potential unwilling to use medically acceptable contraceptive methods (e.g., surgical sterilization, hormonal contraceptives, barrier methods, or intrauterine devices) so as to prevent pregnancy for 12 months following the study procedure
• Have at the time of surgery a systemic infection or local infection at the site of surgery
• Have an active history of systemic malignancy
• Currently has untreated malignant neoplasm(s), or is currently undergoing radio- or chemotherapy or has been diagnosed with hypercalcemia.
• Have a medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study or potentially decrease survival or interfere with ambulation or rehabilitation (e.g., histories of transient ischemic attack (TIA), stroke or liver disease)
• Has a known complication of diabetes (e.g. retinopathy, renal failure, neuropathic complication in lower limb).
• Receiving active treatment with a drug known to interfere with bone metabolism (e.g. long-term steroid therapy, methotrexate).
• Being treated with a bone growth simulator
• Have a medical condition requiring radiation, chemotherapy or immunosuppression.
• Have obvious and/or documented alcohol or illicit drug addictions
• Are prisoners
• Have participated in clinical studies evaluating investigational devices, pharmaceuticals or biologic within 3 months of enrolment