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Ankle Joint Replacement Outcomes Study - NCT00503438-78205(Clinical Trial 177791)



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City:  San Antonio
State:  
TX
Zip Code: 78205
Conditions: Osteoarthritis - Rheumatoid Arthritis - Post-Traumatic Arthritis - Septic Arthritis - Prior Ankle Fusion
Purpose: The purpose of this multi-center study is to look at the results of the Salto Talaris ankle implant as scored by functional outcome and quality of life data. This information will be used to validate and improve the implant, instruments, and surgical technique as well as increase acceptance of the procedure by insurance carriers. Our hypothesis is that the ankle joint replacement will result in better disease-specific quality of life.
Study summary: This is a prospective, multi-center study that will capture the therapeutic results of the Salto Talaris Anatomic ankle prosthesis in the treatment of various ankle afflictions.
Criteria: Inclusion Criteria: - Subjects that need an ankle joint replacement due to arthritis or failed prior fusion. - Subjects who have failed standard conservative management of their ankle condition Exclusion Criteria: - Pregnant women - Class IV or higher anesthetic risk - Subjects who are not able to comply with the study procedures - Known contraindications to joint replacement such as active infection, complete talar necrosis, insufficient quality of bone stock, ligament laxity, severe osteopenia, Charcot's arthropathy - Unwilling to be followed for 5 years
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Data Source: ClinicalTrials.gov
Date Processed: May 21, 2010
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