NCT05619588Recruiting
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
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 370 (estimated)
- First submitted
- 9 Nov 2022
- Start date
- 4 Apr 2017
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Exactech
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05619588
What you commit to
- Study type: Observational
- Planned participants: 370
- From 4 Apr 2017 to the primary completion date, 31 Dec 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with Neuromuscular inadequacy (e.g. Prior paralysis, fusion and or inadequate abductor strength)
- Previous ankle arthrodesis with excision of the malleoli
Other illness
- Patient with Infection at the ankle site or infection at distant sites that could migrate to the ankle
- 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 dementia
- Patient with known metal allergies
Age
- Skeletally immature patients (patient is less than 21 years if age at time of surgery)
Other
- 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 Sepsis
- Patient with Vascular deficiency in the involved limb
- Patient with Neuropathic joints
- Patient with Poor soft tissue coverage around the ankle
- Patient with Charcot arthropathy
- Excessive loads as caused by activity or patient weight - per investigator discretion
- Patient who is pregnant
Who the study is looking for
- 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
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke Department of Orthopaedic Surgery Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.