Ankle Injuries and DisordersNCT04944576
Observational Study to Evaluate Safety and Performance of the Total Ankle Prosthesis, EasyMove®
An observational study of Ankle Injuries and Disorders, run by FH ORTHO at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Injuries and Disorders
- What is being tested?
- Total Ankle Prosthesis, EasyMove®
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 14 Sep 2021to 13 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from participating centres will be enrolled as part of their clinical routine care.
Who may be able to join
- 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
Who cannot join
- Contraindications listed in the instructions for use
- Patient who is not able to express his/her non opposition
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
France5 sites
Chu Brest
Brest, 29609
CH Raymond-Poincaré
Garches, 92380
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85925
Clinique Victor HUGO
Paris, 75008
Clinique Jouvenet
Paris, 75016
Switzerland1 site
Centre hospitalier universitaire vaudois
Lausanne, CH-1011
About this study
Official title: 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.
Read the 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.
- Conditions
- Ankle Injuries and Disorders
- Being tested
- Total Ankle Prosthesis, EasyMove®
- Medical subject headings
- Ankle Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Ankle Prosthesis, EasyMove®Device
Patients who will be implanted with a total ankle prosthesis, EasyMove.
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision rate
Revision rate of the implant for aseptic loosening.
Measured: Up to 5 years of follow-up
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: perop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start14 Sep 2021
- Primary completion13 Sep 2029 (estimated)
- Study completion13 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Injuries and DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- FH ORTHO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944576
- Sponsor's protocol ID
- 2018-42
- Other IDs
- 2020-A03401-38
- Status last verified
- Jul 2026
- First submitted
- 14 Jun 2021
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Multicenter Prospective Clinical Study on the Total Ankle Prosthesis, EasyMove®, Evaluating Safety and Performance up to 5 Years of Follow-up
- ClinicalTrials.gov ID
- NCT04944576
- Acronym / sponsor ID
- 2018-42
- Conditions
- Ankle Injuries and Disorders
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 82 participants (actual)
- Lead sponsor
- FH ORTHOIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 13 Sep 2029 (estimated)
- Study completion
- 13 Sep 2029 (estimated)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from participating centres will be enrolled as part of their clinical routine care.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Contraindications listed in the instructions for use
- Patient who is not able to express his/her non opposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Ankle Prosthesis, EasyMove®Patients who will be implanted with a total ankle prosthesis, EasyMove. | Device | – |
Primary outcome
Revision rate
Time frame: Up to 5 years of follow-up
Revision rate of the implant for aseptic loosening.
7 secondary outcomes
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 outcomes evaluation such as mobility
Time frame: preop, 1 year postop, 2 years postop, 5 years postop
Functional outcomes evaluation such as mobility
Time frame: 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 evaluation such as quality of life
Time frame: preop, 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
Rate of complications
Time frame: perop, 4-6 weeks postop, 1 year postop, 2 years postop, 5 years postop
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Injuries and Disorders, run by FH ORTHO at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revision rate (time frame: Up to 5 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.