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Recruiting
NCT05619588
Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only
Conditions: Ankle Rheumatoid Arthritis, Arthritis of Ankle, Failure, Prosthesis
Sex: All
Ages: 21 Years – N/A
Enrollment: 370
Sponsor: Exactech
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:Patient is indicated for total ankle arthroplastyPatient is skeletally maturePatient is mentally capable of completing follow-up formsPatient will be available for follow-up out to 10 yearsPatient has been deemed a candidate for Ankle replacement by diagnosis of the investigatorPatient is willing and able to read and sign a study informed consent formExclusion Criteria:Patient with excessive bone loss at the ankle joint sitePatient with severe osteoporosisPatient with complete talar avascular necrosisPatient with Active OsteomyelitisPatient with Infection at the ankle site or infection at distant sites that could migrate to the anklePatient with SepsisPatient with Vascular deficiency in the involved limbPatient with Neuromuscular inadequacy (e.g.
Prior paralysis, fusion and or inadequate abductor strength)Patient with Neuropathic jointsPatient with Neurological or musculoskeletal disease or loss of function that may adversely affect movement of the lower limb, gait, or weight bearingPatient with Poor soft tissue coverage around the anklePatient with Charcot arthropathyPrevious ankle arthrodesis with excision of the malleoliExcessive loads as caused by activity or patient weight - per investigator discretionSkeletally immature patients (patient is less than 21 years if age at time of surgery)Patient with dementiaPatient with known metal allergiesPatient who is pregnant
Source: ClinicalTrials.gov (NCT05619588). StuddyBuddy aggregates publicly available trial information.