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

N/ARecruitingNCT05619588

Exactech370 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

370

Conditions

Ankle Rheumatoid Arthritis Arthritis of Ankle Failure, Prosthesis

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (2)

Mayo Clinic

Jacksonville, Florida, United States

RECRUITING

Duke Department of Orthopaedic Surgery

Durham, North Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

AOFAS

American Orthopedic Foot and Ankle Society Score (AOFAS) - Questionaire on pain (40 points), function (45 points) , and alignment (15 points) - 100 points score where 100 indicates a healthy midfoot