Ankle Joint Replacement Outcomes Study

Study Overview
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Brief Summary
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This post market outcome study will look at the therapeutic results of the 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.

Detailed Description
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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.

Official Title
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Salto Talaris Anatomic Ankle Arthroplasty Outcomes Study

Conditions
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Osteoarthritis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Septic Arthritis, Prior Ankle Fusion

Intervention / Treatment
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* Device: Salto Talaris Ankle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Salto Talaris Ankle<br>This is an Implant Registry of the approved Salto Talaris Ankle replacement device | Device: Salto Talaris Ankle<br>* Salto Talaris Anatomic Ankle total joint prosthesis<br>* Other names: Salto Talaris;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship of Salto Talaris Ankle Implant | Count of participants without a failed ankle arthroplasty. Ankle arthroplasty will be considered as failed if the implant is revised or removed and the ankle fused. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The American Orthopaedic Foot and Ankle Society (AOFAS) Score | AOFAS ankle evaluation form is a commonly used standardized assessment of foot and ankle function divided into three anatomic regions. The scale used for this study will be the Ankle-Hindfoot Scale that ranges from 0 to 100. A score of 100 points is the maximum for a patient presenting in excellent condition. The score decreases as pain, limited range of motion, daily activities, joint instability, and alignment are assessed. | Postoperatively at 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthritis, Osteoarthritis, Arthroplasty