Ankle Joint Replacement Outcomes Study
This trial is active, not recruiting.
|Conditions||osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, septic arthritis, prior ankle fusion|
|Treatment||salto talaris ankle|
|Sponsor||Wright Medical Group|
|Start date||July 2007|
|End date||December 2016|
|Trial size||200 participants|
|Trial identifier||NCT00503438, 2006.ST01US|
This post market outcome study will look at the therapeutic results of Tornier's FDA 510(k) cleared Salto Talaris Anatomic ankle prosthesis. The study population will consist of patients who will undergo an ankle arthroplasty procedure with a Salto Talaris ankle implant. An analysis will be conducted of the results, complications and revisions of this prosthesis based on the etiology for which the ankle arthroplasty was performed.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
This is an Implant Registry of the approved Salto Talaris Ankle replacement device
time frame: 5+ years
American Orthopaedic Foot and Ankle Society ankle evaluation, Foot Function Index (FFI), Foot and Ankle Ability Measure (FAAM)
time frame: 5+ years
Male or female participants at least 18 years old.
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: - 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
|Official title||Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study|
|Principal investigator||Richard Marks|
|Description||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.|
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