Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Recruiting Locations

Mayo Clinic
Jacksonville, Florida 32224

Duke Department of Orthopaedic Surgery
Durham, North Carolina 27703

More Details

Status
Recruiting
Sponsor
Exactech

Study Contact

Rachael Craig
352-377-1140
rachael.craig@exac.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.