Clinical Trials

Inclusion 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

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

- 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 3/23/23. Questions regarding updates should be directed to the study team contact.