NCT05691868Recruiting
Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)
An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System (Outside US)
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 Mobile-Bearing Total Angle System. This study will follow subjects for a period of up to 10 years post-surgery.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 11 Jan 2023
- Start date
- 8 Apr 2019
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Exactech
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05691868
What you commit to
- Study type: Observational
- Planned participants: 400
- From 8 Apr 2019 to the primary completion date, 31 Dec 2030
- 2 sites in 2 countries
- 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.
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
- Pateint with neuropathic joints
- Patient with poor soft tissue coverage around the ankle
- Patient with Charcot arthropathy
- Previsous ankle arthrodesis with excision of the malleoli
- Excessive loads as cuased by activity or patient weight - per investigator discretion
- Patients who are unwilling to provide informed consent
- Patients who are unlikely to be available for follow-up out to 10 years
- Patients who are not deemed suitable candidates for the subject device
- Patient is pregnant
Who the study is looking for
- Patient is indicated for total ankle arthroplasty
- Patient is at least 21 years of age
- Patient is likely to be available for follow-up out to 10 years
- Patient is willing to participate by complying with pre- and postoperative visit requirements
- 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 |
|---|---|---|---|
| SWISS ORTHO CENTER Pain Clinic Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Hospital Universitario de Canarias Coordinator of this site? Confirm its status | Santa Cruz de Tenerife | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.