Evaluating the Vantage Mobile Bearing Total Ankle System after surgery

An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System (Outside US)

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
• Enrollment: 400 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Exactech (industry)
• Locations: 2 sites (Santa Cruz de Tenerife and 1 other locations)
• Trial ID: NCT05691868 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients with severe bone loss, infections, or other significant comorbidities affecting the ankle may not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Santa Cruz de Tenerife and 1 other locations

• 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

Conditions: Rheumatoid Arthritis, Arthritis of Ankle, Failure, Prosthesis