Observational Study to Evaluate Safety and Performance of the Total Ankle Prosthesis, EasyMove®

Study Overview
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Brief Summary
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This study is a post-market clinical follow-up conducted in order to collect long-term data on safety and performance of the EasyMove prosthesis, which is intended to be implanted in case of total ankle replacement, when used in real life conditions according to the instructions for use.

Detailed Description
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The primary objective is to evaluate the safety of the total ankle prosthesis, EasyMove, up to five years of follow-up. The secondary objectives are to evaluate both the safety and the performance of the total ankle prosthesis, EasyMove, up to five years of follow-up.

Official Title
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Observational Multicenter Prospective Clinical Study on the Total Ankle Prosthesis, EasyMove®, Evaluating Safety and Performance up to 5 Years of Follow-up

Conditions
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Ankle Injuries and Disorders

Intervention / Treatment
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* Device: Total Ankle Prosthesis, EasyMove®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient implanted with the studied device according to the instructions for use, for primary surgery in patients with ankle joints damaged by severe rheumatoid, post-traumatic or degenerative arthritis Adult patient (≥18 years old) Patient who received an information form and is willing to participate in the study Exclusion Criteria: Contraindications listed in the instructions for use Patient who is not able to express his/her non opposition

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Total Ankle Prosthesis, EasyMove®|Patients who will be implanted with a total ankle prosthesis, EasyMove.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision rate | Revision rate of the implant for aseptic loosening. | Up to 5 years of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcomes evaluation such as pain and mobility | Functional ouctomes will be evaluated through the AOFAS score. This score is comprised of nine questions covering three categories: pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. The higher the score, the better the patient outcome. AOFAS is a clinician reporting tool that required both patient and provider participation to be fully complete. | preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop | 
| Functional outcomes evaluation such as mobility | Functional ouctomes will be evaluated through the FAAM score. This score is a 29-item questionnaire divided into two subscales: 21-item Activities of Daily Living Subscale and 8-item Sports Subscale. Item score totals, which range from 0 to 84 for the Activities of Daily Living subscale and 0 to 32 for the Sports subscale, are transformed to percentage scores. The higher the score, the better the patient outcomes. It is a self-report outcome instrument. | preop, 1 year postop, 2 years postop, 5 years postop | 
| Functional outcomes evaluation such as mobility | Functional ouctomes will be evaluated through clinical data such as the range of motion. | preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop | 
| Health status outcomes evaluation such as pain | Health status outcomes will be evaluated through a visual analogue scale to measure pain. | preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop | 
| Health status outcomes evaluation such as quality of life | Health status outcomes will be evaluated through the SF-12 questionnaire to measure the quality of life. It is a self-reported outcome measure, composed of 12 questions. It provides an eight-scale profile of functional health and wellbeing, as well as two psychometrically based physical and mental health summary measures, scored on a T-score metric. The higher the score, the better the patient outcomes. | preop, 1 year postop, 2 years postop, 5 years postop | 
| Radiological data evaluation | Radiological data results such as the postion of the implant, lucency, calcification will be evaluated. | preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop | 
| Rate of complications | All complications will be gathered from the intervention up to 5 years of follow-up. | perop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop |