Evaluating the Vantage Total Ankle System after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the performance and safety of the Vantage Total Ankle System in patients undergoing total ankle arthroplasty. Participants will be followed for up to 10 years post-surgery to gather data on outcomes and any complications. The study includes patients who are skeletally mature and mentally capable of completing follow-up forms, ensuring a comprehensive evaluation of the device's long-term effectiveness. The study is conducted at prominent medical centers in the United States.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient is indicated for total ankle arthroplasty
* Patient is skeletally mature
* Patient is mentally capable of completing follow-up forms
* Patient will be available for follow-up out to 10 years
* Patient has been deemed a candidate for Ankle replacement by diagnosis of the investigator
* 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
* Patient with Neuromuscular inadequacy (e.g. Prior paralysis, fusion and or inadequate abductor strength)
* Patient 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
* Previous ankle arthrodesis with excision of the malleoli
* Excessive loads as caused 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
* Patient who is pregnant

Where it's running

• Mayo Clinic
  Jacksonville, Florida, United States Recruiting
• Duke Department of Orthopaedic Surgery
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Samuel Adams, MD — Duke Department of Orthopaedic Surgery
• Study coordinator: Rachael Craig
• Email: rachael.craig@advita.com
• Phone: 1-833-423-8482

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.