Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only

Exactech

Status: Enrolling

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05619588

CR16-002

Details and patient eligibility

About

The objectives of this study are to evaluate the performance and safety of the Vantage Total Ankle System. This study will follow subjects for a period of up to 10 years post-surgery.

Enrollment: 370 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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