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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A03401-38 | Registry Identifier | French registry related to the ANSM (ID-RCB) |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Ankle Prosthesis, EasyMove® | Device | Patients who will be implanted with a total ankle prosthesis, EasyMove. |
| Measure | Description | Time Frame |
|---|---|---|
| Revision rate | Revision rate of the implant for aseptic loosening. | Up to 5 years of follow-up |
| 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. The AOFAS score will be compared to its MCID at each follow-up visit. The MCID will be calculated based on the distribution-based MCID method. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from participating centres will be enrolled as part of their clinical routine care.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Brest | Brest | 29609 | France | |||
| CH Raymond-Poincaré |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. The FAAM score will be compared to its MCID at each follow-up visit. The Minimal Clinically Important Difference (MCID) of the Foot and Ankle Ability Measure (FAAM) at 1 year of follow-up compared to the theorical MCID retrieved in the literature (MCID = 31.2 (sd=25.3, superiority comparison)). For the following follow-up, the MCID will be calculated based on the distribution-based MCID method. | 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. The SF-12 score will be compared to its MCID at each follow-up visit. The MCID will be calculated based on the distribution-based MCID method. | 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 |
| Garches |
| 92380 |
| France |
| Centre Hospitalier Départemental Vendée | La Roche-sur-Yon | 85925 | France |
| Clinique Victor HUGO | Paris | 75008 | France |
| Clinique Jouvenet | Paris | 75016 | France |
| Centre hospitalier universitaire vaudois | Lausanne | CH-1011 | Switzerland |