Observational Study to Evaluate Safety and Performance of the Total Ankle Prosthesis, EasyMove®
- Conditions
- Ankle Injuries and Disorders
- Registration Number
- NCT04944576
- Lead Sponsor
- FH ORTHO
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 82
- 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
- Contraindications listed in the instructions for use
- Patient who is not able to express his/her non opposition
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Revision rate Up to 5 years of follow-up Revision rate of the implant for aseptic loosening.
- Secondary Outcome Measures
Name Time 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.
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.
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.
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.
Functional outcomes evaluation such as mobility preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop Functional ouctomes will be evaluated through clinical data such as the range of motion.
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.
Trial Locations
- Locations (6)
CH Raymond-Poincaré
🇫🇷Garches, France
Clinique Jouvenet
🇫🇷Paris, France
Centre hospitalier universitaire vaudois
🇨🇭Lausanne, Switzerland
Chu Brest
🇫🇷Brest, France
Clinique Victor HUGO
🇫🇷Paris, France
Centre Hospitalier Départemental Vendée
🇫🇷La Roche-sur-yon, France