Evaluating the Vantage Total Ankle System after surgery

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

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.

Quick facts

• Study type: Observational
• Enrollment: 370 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Exactech (industry)
• Locations: 2 sites (Jacksonville, Florida and 1 other locations)
• Trial ID: NCT05619588 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the performance and safety of the Vantage 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 are skeletally mature and mentally capable of completing follow-up forms, ensuring a comprehensive evaluation of the device's long-term effectiveness. The study is conducted at prominent medical centers in the United States.

Who should consider this trial

Good fit: Ideal candidates include patients indicated for total ankle arthroplasty who are skeletally mature 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 provide valuable insights into the long-term safety and effectiveness of the Vantage Total Ankle System for patients with ankle arthritis.

How similar studies have performed: Other studies evaluating total ankle arthroplasty have shown promising results, indicating that this approach is supported by existing evidence.

Eligibility criteria

Inclusion Criteria:

* 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

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
* Patient with Neuromuscular inadequacy (e.g. Prior paralysis, fusion and or inadequate abductor strength)
* Patient 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
* Previous ankle arthrodesis with excision of the malleoli
* Excessive loads as caused 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
* Patient who is pregnant

Where this trial is running

Jacksonville, Florida and 1 other locations

• Mayo Clinic — Jacksonville, Florida, United States (RECRUITING)
• Duke Department of Orthopaedic Surgery — Durham, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Samuel Adams, MD — Duke Department of Orthopaedic Surgery
• Study coordinator: Rachael Craig

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