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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ankle Injuries and Disorders
• Intervention / Treatment: Device: Total Ankle Prosthesis, EasyMove®

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.

• Study Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHU Brest
  • Garches, France, 92380
    • CH Raymond-Poincaré
  • La Roche-sur-yon, France, 85925
    • Centre Hospitalier Departemental Vendee
  • Paris, France, 75016
    • Clinique Jouvenet
  • Paris, France, 75008
    • Clinique Victor Hugo
• Switzerland
  • Lausanne, Switzerland, CH-1011
    • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients from participating centres will be enrolled as part of their clinical routine care.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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 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
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
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.	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
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

Collaborators and Investigators

• Sponsor: FH ORTHO

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Estimated): September 13, 2029
• Study Completion (Estimated): September 13, 2029

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries
• Other Study ID Numbers: 2018-42; 2020-A03401-38 (Registry Identifier: French registry related to the ANSM (ID-RCB))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No