Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * Patient is indicated for total ankle arthroplasty
- * Patient is skeletally mature
- * Patient is mentally capable of completing follow-up forms
- * Patient will be available for follow-up out to 10 years
- * Patient has been deemed a candidate for Ankle replacement by diagnosis of the investigator
- * Patient is willing and able to read and sign a study informed consent form
- * Patient with excessive bone loss at the ankle joint site
- * Patient with severe osteoporosis
- * Patient with complete talar avascular necrosis
- * Patient with Active Osteomyelitis
- * Patient with Infection at the ankle site or infection at distant sites that could migrate to the ankle
- * Patient with Sepsis
- * Patient with Vascular deficiency in the involved limb
- * Patient with Neuromuscular inadequacy (e.g. Prior paralysis, fusion and or inadequate abductor strength)
- * Patient with Neuropathic joints
- * Patient with Neurological or musculoskeletal disease or loss of function that may adversely affect movement of the lower limb, gait, or weight bearing
- * Patient with Poor soft tissue coverage around the ankle
- * Patient with Charcot arthropathy
- * Previous ankle arthrodesis with excision of the malleoli
- * Excessive loads as caused by activity or patient weight - per investigator discretion
- * Skeletally immature patients (patient is less than 21 years if age at time of surgery)
- * Patient with dementia
- * Patient with known metal allergies
- * Patient who is pregnant
Ages Eligible for Study
21 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No