RecruitingNCT05619588
Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only
An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System
Sponsor
Exactech
Enrollment
370 participants
Start Date
Apr 4, 2017
Study Type
OBSERVATIONAL
Conditions
Summary
The objectives of this study are to evaluate the performance and safety of the Vantage Total Ankle 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 collecting long-term follow-up data from patients who receive the Exactech Vantage total ankle replacement system — an artificial ankle joint — to assess how well it works and how safe it is over 10 years in routine US clinical practice.
**You may be eligible if...**
- You are skeletally mature (bones fully developed) and have been recommended for total ankle replacement by your surgeon
- You are mentally capable of completing follow-up questionnaires
- You are available for follow-up visits for up to 10 years
- You are willing to read and sign an informed consent form
**You may NOT be eligible if...**
- You have severe bone loss or severe osteoporosis at the ankle
- You have a bone infection (osteomyelitis) or active infection near the ankle
- You have poor blood supply or nerve damage in the affected leg
- You have a condition like Charcot arthropathy (a nerve-related joint disease)
- You have had a previous ankle fusion that removed the ankle bones
- You are pregnant
- You have a known metal allergy
- You are skeletally immature (under 21 years old)
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05619588