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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 21 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 10 years
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "This study will follow subjects for a period of up to 10 years post-surgery."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe the Vantage Total Ankle System is and how well it works. It is for people who need a total ankle replacement and will follow them for up to 10 years after surgery.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Need a total ankle replacement and be judged a good candidate by the study doctor.
- Have fully grown bones.
- Be mentally able to complete follow-up forms.
- Be available for follow-up visits for up to 10 years.
- Be willing and able to read and sign a form agreeing to join the study.
Who can't join
- Too much bone loss in the ankle, very weak bones (severe osteoporosis), or death of the entire talus bone from lost blood flow.
- An active bone infection, an ankle infection, another infection that could spread to the ankle, or sepsis (a serious body-wide response to infection).
- Poor blood flow in the leg with the affected ankle, or too little soft tissue covering the ankle.
- Poor nerve or muscle function, such as past paralysis, joint fusion, or weak muscles; or a nerve, muscle, or bone condition that could harm leg movement, walking, or weight bearing.
- Joint damage from nerve problems, including Charcot joint disease.
- Past ankle fusion surgery that removed the bony bumps on the sides of the ankle.
- Activity or body weight that puts too much load on the ankle, as judged by the study doctor.
- Under age 21 at surgery, dementia, known metal allergies, or pregnancy.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (2)
FL
- Mayo Clinic · Jacksonville, FL 32224More trials in Jacksonville
NC
- Duke Department of Orthopaedic Surgery · Durham, NC 27703More trials in Durham