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RECRUITINGOBSERVATIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form Who Should NOT Join This Trial: - 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 willing to sign a consent form - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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
SWISS ORTHO CENTER Pain Clinic Basel
Basel, Switzerland