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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion, an average of 1 per year |
| 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 | Through study completion, an average of 1 per year |
| 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 | Through study completion, an average of 1 per year |
| 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 | Through study completion, an average of 1 per year |
| VAS Pain score and Patient Satisfaction | Visual Analog Scale (VAS) Score - Range of scores from 0-100 to indicate level of pain - Higher score indicates greater pain intensity | Through study completion, an average of 1 per year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachael Craig | Contact | 352-377-1140 | rachael.craig@exac.com | |
| Sandrine Angibaud | Contact | 352-377-1140 | sandrine.angibaud@exac.com |
| Name | Affiliation | Role |
|---|---|---|
| Victor Valderrabano, MD, PhD | SWISS ORTHO CENTER Pain Clinic Basel | Principal Investigator |
| Mario Herrera- Perez, MD, PhD | Hospital Universitario de Canarias | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Canarias | Recruiting | Santa Cruz de Tenerife | 38320 | Spain |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D011475 | Prosthesis Failure |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| SWISS ORTHO CENTER Pain Clinic Basel | Recruiting | Basel | CH-4010 | Switzerland |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |