Ankle Injuries and Disorders
Conditions
Brief summary
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
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.
Interventions
DEVICETotal Ankle Prosthesis, EasyMove®
Patients who will be implanted with a total ankle prosthesis, EasyMove.
Sponsors
FH ORTHO
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revision rate | Up to 5 years of follow-up | Revision rate of the implant for aseptic loosening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcomes evaluation such as pain and mobility | preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop | 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. |
| Functional outcomes evaluation such as mobility | preop, 1 year postop, 2 years postop, 5 years postop | 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. |
| Health status outcomes evaluation such as pain | preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop | Health status outcomes will be evaluated through a visual analogue scale to measure pain. |
| Health status outcomes evaluation such as quality of life | preop, 1 year postop, 2 years postop, 5 years postop | 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. |
| Radiological data evaluation | preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop | Radiological data results such as the postion of the implant, lucency, calcification will be evaluated. |
| Rate of complications | perop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop | All complications will be gathered from the intervention up to 5 years of follow-up. |
Countries
France, Switzerland
Outcome results
None listed