Overview
The objectives of this study are to evaluate the performance and safety of the Vantage Mobile-Bearing Total Angle System. This study will follow subjects for a period of up to 10 years post-surgery.
Eligibility
Inclusion Criteria:
- Patient is indicated for total ankle arthroplasty
- Patient is at least 21 years of age
- Patient is likely to be available for follow-up out to 10 years
- Patient is willing to participate by complying with pre- and postoperative visit requirements
- Patient is willing and able to read and sign a study informed consent form
Exclusion Criteria:
- 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
- Pateint 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
- Previsous ankle arthrodesis with excision of the malleoli
- Excessive loads as cuased 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
- Patients who are unwilling to provide informed consent
- Patients who are unlikely to be available for follow-up out to 10 years
- Patients who are not deemed suitable candidates for the subject device
- Patient is pregnant