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Clinical Trials in Spain / NCT05691868
Recruiting Observational

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

NCT05691868 · tracked via the Priya Life Science Spain tracker
Sponsor
Exactech
Phase
Observational
Started
2019-04-08
Last updated
2026-09-16

Condition(s) studied

Rheumatoid ArthritisArthritis of AnkleFailure, Prosthesis

Study summary

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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
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

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 score and Patient Satisfaction — 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)

FacilityCityRegionStatus
Hospital Universitario de Canarias Santa Cruz de Tenerife Spain Recruiting
SWISS ORTHO CENTER Pain Clinic Basel Basel Switzerland Recruiting

More Exactech trials in Spain

Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment Recruiting

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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 NCT05691868 on ClinicalTrials.gov ↗ ← All trials in Spain