Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System (Outside US)

Conditions
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Rheumatoid Arthritis, Arthritis of Ankle, Failure, Prosthesis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AOFAS | American Orthopedic Foot and Ankle Society Score (AOFAS) - Questionaire on pain (40 points), function (45 points) , and alignment (15 points) - 100 points score where 100 indicates a healthy midfoot | Through study completion, an average of 1 per year | 
| SMFA | Short Musculoskeletal Function Assessment (SMFA) Score - 46 items Patient questionnaire divided into two sections: 34 questions on patients function assessment and 12 questions covering how bothered patients are by their symptoms where 1 indicates no problems/no difficulty/ not bothered and 5 indicates unable to do/symptoms all the time/being greatly bothered | Through study completion, an average of 1 per year | 
| SF-36 | Short Form Health Survey (SF-36) Score - 36-item patient-reproted survey of patient health - It consists on 8 scales: Physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each scale is transformed into a 0-100 scale where the lower score indicates the more disability and the higher score the lest disability | Through study completion, an average of 1 per year | 
| Sports Frequency Score | Sports Frequency Score - Level of sport activity in leisure time where 0 indicates no sports activity and 4 indicates professional level of sports activity, elite athlete | Through study completion, an average of 1 per year | 
| VAS Pain score and Patient Satisfaction | Visual Analog Scale (VAS) Score - Range of scores from 0-100 to indicate level of pain - Higher score indicates greater pain intensity | Through study completion, an average of 1 per year |