Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)

Exactech

Status: Enrolling

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05691868

CR16-004

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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