Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is indicated for total ankle arthroplasty
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Patient is at least 21 years of age
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Patient is likely to be available for follow-up out to 10 years
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Patient is willing to participate by complying with pre- and postoperative visit requirements
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Patient is willing and able to read and sign a study informed consent form
Exclusion Criteria:
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Patient with excessive bone loss at the ankle joint site
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Patient with severe osteoporosis
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Patient with complete talar avascular necrosis
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Patient with active osteomyelitis
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Patient with infection at the ankle site or infection at distant sites that could migrate to the ankle
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Patient with sepsis
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Patient with vascular deficiency in the involved limb
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Pateint with neuropathic joints
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Patient with neurological or musculoskeletal disease or loss of function that may adversely affect movement of the lower limb, gait, or weight bearing
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Patient with poor soft tissue coverage around the ankle
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Patient with Charcot arthropathy
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Previsous ankle arthrodesis with excision of the malleoli
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Excessive loads as cuased by activity or patient weight - per investigator discretion
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Skeletally immature patients (patient is less than 21 years if age at time of surgery)
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Patient with dementia
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Patient with known metal allergies
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Patients who are unwilling to provide informed consent
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Patients who are unlikely to be available for follow-up out to 10 years
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Patients who are not deemed suitable candidates for the subject device
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Patient is pregnant
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hospital Universitario de Canarias | Santa Cruz De Tenerife | Spain | 38320 | |
2 | SWISS ORTHO CENTER Pain Clinic Basel | Basel | Switzerland | CH-4010 |
Sponsors and Collaborators
- Exactech
Investigators
- Principal Investigator: Victor Valderrabano, MD, PhD, SWISS ORTHO CENTER Pain Clinic Basel
- Principal Investigator: Mario Herrera- Perez, MD, PhD, Hospital Universitario de Canarias
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR16-004