RecruitingNCT05691868

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)


Sponsor

Exactech

Enrollment

400 participants

Start Date

Apr 8, 2019

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is a long-term follow-up study tracking the outcomes of people outside the United States who have received a Vantage Mobile Bearing Total Ankle replacement — an artificial ankle joint — to assess how well the device works and how safe it is over 10 years. **You may be eligible if...** - You are 21 years or older - You are scheduled for or have received a total ankle replacement using the Vantage system - You are likely to be available for follow-up visits over 10 years - You are willing and able to sign consent and attend required appointments **You may NOT be eligible if...** - You have severe bone loss, severe osteoporosis, or dead bone (avascular necrosis) in the ankle - You have an active infection near or in the ankle, or a systemic infection - You have Charcot arthropathy (nerve-related joint damage), neuropathic joints, or poor circulation in the leg - You have dementia or known metal allergies - You are under 21 years old or skeletally immature - You are unlikely to be available for long-term follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

SWISS ORTHO CENTER Pain Clinic Basel

Basel, Switzerland

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NCT05691868


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