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NCT05619588Recruiting

Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only

Exactech

Start Date

4/4/2017

Completion Date

9/30/2031

Summary

The objectives of this study are to evaluate the performance and safety of the Vantage Total Ankle System. This study will follow subjects for a period of up to 10 years post-surgery.

Eligibility Criteria

Age Range: 21 years to No maximum

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

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Conditions

Ankle Rheumatoid ArthritisArthritis of AnkleFailure, Prosthesis

Locations

Mayo Clinic

Jacksonville, Florida 32224

United States

Duke Department of Orthopaedic Surgery

Durham, North Carolina 27703

United States