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

Exactech400 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Rheumatoid Arthritis Arthritis of Ankle Failure, Prosthesis

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (2)

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

RECRUITING

SWISS ORTHO CENTER Pain Clinic Basel

Basel, Switzerland

RECRUITING

Outcomes

Primary Outcomes

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