Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorExactech
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient with excessive bone loss at the ankle joint site
Patient with severe osteoporosis
Patient with complete talar avascular necrosis
Patient with active osteomyelitis
Trial population
Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
Through study completion, an average of 1 per year2
SMFA
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
Time frame
Through study completion, an average of 1 per year3
SF-36
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
Time frame
Through study completion, an average of 1 per year4
Sports Frequency Score
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
Time frame
Through study completion, an average of 1 per year Source ClinicalTrials.gov