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

Summary

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.

Eligibility

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

Conditions4

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