Clinical Trials in the USA / NCT05619588
Recruiting
Observational
Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only
NCT05619588 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Ankle Rheumatoid ArthritisArthritis of AnkleFailure, Prosthesis
Study 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
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
Primary outcome measure(s)
- AOFAS — Through study completion, an average of 1 per year
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 - SMFA — Through study completion, an average of 1 per year
Short Musculoskeletal Function Assessment (SMFA) Score - 46 items Patient questionnaire divided into two sections: 34 questions on patients function assessment and 12 questions covering how bothered patients are by their symptoms where 1 indicates no problems/no difficulty/ not bothered and 5 indicates unable to do/symptoms all the time/being greatly bothered - SF-36 — Through study completion, an average of 1 per year
Short Form Health Survey (SF-36) Score - 36-item patient-reproted survey of patient health - It consists on 8 scales: Physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each scale is transformed into a 0-100 scale where the lower score indicates the more disability and the higher score the lest disability - Sports Frequency Score — Through study completion, an average of 1 per year
Sports Frequency Score - Level of sport activity in leisure time where 0 indicates "no sports activity" and 4 indicates "professional level of sports activity, elite athlete - VAS Pain and Patient Satisfaction Score — Through study completion, an average of 1 per year
Visual Analog Scale (VAS) Score - Range of scores from 0-100 to indicate level of pain - Higher score indicates greater pain intensity
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | Recruiting |
| Duke Department of Orthopaedic Surgery | Durham | North Carolina | Recruiting |
More Exactech trials in the USA
Optetrak Knee System Post Market Clinical Follow-Up
Active, not recruiting
Exactech Knee Systems Post Market Clinical Follow-up
Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05619588 on ClinicalTrials.gov ↗ ← All trials in the USA