NCT05619588 · Exactech
Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Jacksonville, Florida
- Durham, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2025 · Source of record for eligibility and locations