A new ankle? researchers track 400 people with an implant meant to restore movement
NCT ID NCT05691868
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are studying the Exactech Vantage Mobile-Bearing Total Ankle System, an implant used to replace a damaged ankle joint. The study enrolls 400 adults with ankle arthritis or related joint failure who are scheduled for total ankle replacement. Participants receive the implant and are followed for up to 10 years, with researchers measuring pain, function, alignment, and quality of life through standard questionnaires and tracking safety over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Exactech Vantage Mobile-Bearing Total Ankle System, a total ankle replacement implant
- What this could lead to
- If the implant performs well, it could offer people with painful ankle arthritis a durable replacement option that restores movement and reduces pain for years.
- What could go wrong
- This is a single-arm study with no comparison group, so improvements may reflect surgery and recovery rather than the implant itself. Implants can loosen, wear, or fail over time, and some participants may need further surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2019
- Expected to finish
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Sep 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 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 * Pateint 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 * Previsous ankle arthrodesis with excision of the malleoli * Excessive loads as cuased 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Universitario de Canarias
RECRUITINGSanta Cruz de Tenerife, 38320, Spain
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SWISS ORTHO CENTER Pain Clinic Basel
RECRUITINGBasel, CH-4010, Switzerland
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