Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only
Recruiting · NCT05619588 · Observational (researchers observe without assigning treatment) · Lead sponsor: Exactech
View the official record on ClinicalTrials.gov →What this trial 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.
Who can take part
Age range
21 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
2 locations listed across 2 US states.
- Mayo Clinic - Jacksonville, Florida, United States
- Duke Department of Orthopaedic Surgery - Durham, North Carolina, United States