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

July 1, 2026 updated by: FH ORTHO

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Clinical project manager
  • Phone Number: 0033631315494
  • Email: c.lai@fhortho.com

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Revision rate
Time Frame: Up to 5 years of follow-up
Revision rate of the implant for aseptic loosening.
Up to 5 years of follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional outcomes evaluation such as mobility
Time Frame: 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.
preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
Health status outcomes evaluation such as pain
Time Frame: 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.
preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
Radiological data evaluation
Time Frame: 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.
preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
Rate of complications
Time Frame: 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.
perop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
Functional outcomes evaluation such as pain and mobility
Time Frame: 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.
preop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
Functional outcomes evaluation such as mobility
Time Frame: 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.
preop, 1 year postop, 2 years postop, 5 years postop
Health status outcomes evaluation such as quality of life
Time Frame: 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.
preop, 1 year postop, 2 years postop, 5 years postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
FH ORTHO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 13, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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