Evaluating the Vantage Mobile Bearing Total Ankle System after surgery
Official title: An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System (Outside US)
Run by Exactech · NCT05691868 · Data updated 2026-11-12
This study is testing how well the Vantage Mobile-Bearing Total Ankle System works and if it's safe for people who have had ankle replacement surgery, by following them for up to 10 years after their operation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Exactech Industry-sponsored |
| Locations | 2 sites (Santa Cruz de Tenerife and 1 other locations) |
| Status | Recruiting |
| Started | April 8, 2019 |
| Main results expected | December 31, 2030 |
| Study ends | September 30, 2031 |
| Registry record updated | September 16, 2026 |
| Trial ID | NCT05691868 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 21 and older who are indicated for total ankle arthroplasty and can commit to long-term follow-up.
✕Probably not a fit
Patients with severe bone loss, infections, or other significant comorbidities affecting the ankle may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the performance and safety of the Vantage Mobile-Bearing Total Ankle System in patients undergoing total ankle arthroplasty. Participants will be followed for up to 10 years post-surgery to gather data on outcomes and any complications. The study includes patients who meet specific criteria and are willing to comply with follow-up requirements. It is designed to provide insights into the long-term effectiveness of this ankle prosthesis.
Why it matters
Potential benefit: If successful, this study could improve the understanding of the Vantage Mobile-Bearing Total Ankle System's long-term safety and performance, potentially leading to better treatment options for patients with ankle arthritis.
How similar studies have gone: While this study is observational and focuses on a specific device, similar studies evaluating total ankle arthroplasty have shown promising results in improving patient outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain Recruiting -
SWISS ORTHO CENTER Pain Clinic Basel
Basel, Switzerland Recruiting
Study contacts
- Principal investigator: Victor Valderrabano, MD, PhD — SWISS ORTHO CENTER Pain Clinic Basel
- Study coordinator: Rachael Craig
- Email: rachael.craig@advita.com
- Phone: 1-833-423-8482
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating the Vantage Total Ankle System after surgery
This study is testing how well the Vantage Total Ankle System works and its safety for people who have had ankle replacement surgery, following them for up to 10 years.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.